Medical Device Correction - August 2008
Prostiva® RF Model 8929 Hand Piece Needle Retraction Failure

Medtronic is issuing this Urgent Medical Device Correction to notify physicians of reported incidents of needle retraction failure when using the Prostiva RF Model 8929 Hand Piece. Included in this letter is the Prostiva Hand Piece Disassembly Procedure that should be followed in the event the user is unable to retract the needles during a procedure. The Medtronic Prostiva RF Model 8929 Hand Piece is the delivery system component of the Prostiva RF Therapy System.

Please note that Medtronic is not asking for the return of any Prostiva devices or systems. This information is intended to reduce the risks to patients should this failure mode occur. Existing Prostiva Hand Piece Model 8929 Hand Pieces can continue to be used.

Explanation of the Issue

Medtronic has received customer reports of needle retraction failure when using the Prostiva Hand Piece Model 8929. Based on the available data, the complaint rate is 0.054% and the rate of patient injury (excessive bleeding) associated with this issue is 0.0073% of devices sold. There have been no reports of patient death associated with this issue. However, if the Hand Piece fails prior to completion of a procedure, the risks to patients include the need to undergo an additional pre-op procedure including local anaesthesia, and if the device is withdrawn with partially deployed needles, the deployed needles may lacerate the patient's urethra wall.

This needle retraction failure is the result of loss of mechanical connectivity between the handle lever and an internal component of the Hand Piece that deploys and retracts the needles. In the rare circumstance that this occurs, you may disassemble or withdraw the Hand Piece according to the following procedure.

Prostiva® RF Model 8929 Hand Piece Disassembly Procedure

This disassembly procedure involves separating the metal urethra tube from the plastic handle assembly. Medtronic recommends that two people work together to disassemble the Hand Piece. It is recommended that one individual grips and stabilizes the metal urethra tube, while another individual rotates the gray plastic Hand Piece.

Step 1

If the handle lever is broken (blue handle lever is loose), use the camera to verify that the needles are deployed. If the needles are not deployed, the Hand Piece can be removed normally. Note: Do not use the “backup” retraction method described in the Instructions for Use, Prostiva RF 8929 Therapy Kit (Document # A11736001 or A11736002) for the failure of the needles to retract due to broken/loose blue handle lever. Follow the instructions described below to retract the needles.

It is critical to avoid movement of the metal urethra tube and the needles while attempting this disassembly procedure.


Above: Illustration showing needles deployed and needles withdrawn.

Step 2

Disconnect the camera and light source, remove the telescope from the Hand Piece and disconnect the Hand Piece cable from the generator.

Step 3

Locate a Hemoclip, Clamp, or Needle Holder, with teeth, as illustrated, or an alternate clamping tool. Assure that the clamping device is antiseptically cleaned. This is used to securely stabilize the metal urethra tube.

Step 4

Using a clamping device with teeth, securely clamp the metal urethra tube and stabilize it. It is acceptable to slightly deform the metal urethra tube, but do not flatten or crush the tube completely. Do not allow the metal urethra tube to move in any direction or rotate around its longitudinal axis.

Step 5

Next, GENTLY rotate the gray plastic hand piece from side to side around its longitudinal axis to break the adhesive joint. Do not rotate the plastic hand piece beyond 30 degrees in either direction.

The plastic handle cannot fully rotate due to an alignment feature on the metal tube. Do not attempt to rotate beyond 30 degrees in either direction.

Step 6

After the adhesive joint is broken, gently pull straight backward on the plastic hand piece (along the longitudinal axis) while continuing to rotate the plastic hand piece from side to side around its longitudinal axis. Separate at least 25 mm (1 inch)

Step 7

Once the hand piece and metal tube are separated by at least 25mm (1 inch), the needles are fully withdrawn from the patient and the metal tube may be removed from the patient. It is not necessary to completely separate the plastic hand piece from the metal tube. Attempting to completely separate the plastic hand piece from the metal tube may cause a sudden jerking motion.

In the event the Hand Piece cannot be disassembled, the failed device with extended needles can be withdrawn from the patient using a straight motion and without side-to-side or rotational movement. This method may result in a straight laceration of the urethra wall caused by the extended needles. In such a case, the physician should use standard of care to monitor and treat the patient for possible excessive bleeding. Physician feedback states that the epithelium is fast growing tissue that can replace itself within two weeks, including after severe trauma such as that associated with TURP (transurethral resection of prostate) or laser ablation.

For Further Assistance

In the United States, contact Medtronic Neuromodulation Technical Services at 800-707-0933 or your local Medtronic representative. Outside of the United States, contact your local Medtronic Representative.