MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS PHOENIX; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	401451
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions for an evaluation.A review of the device history record indicates the device met all inspection and test criteria prior to release.Upon visual inspection of the received complaint device, the shaft was identified to be broken at the transition point, and the internal wires appeared to be exposed and intact.The most likely root cause is a broken shaft as a result of mishandling, including shipping and storage conditions, subsequent to distribution from stryker.The instructions for use (ifu) states: do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use.Avoid excessive torque, stretching, kinking and/or bending of catheter, as this may interfere with distal tip shaping or cause damage to internal electrode wires.Avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters.Handle catheter with care to avoid improper electrical functioning.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the wires became exposed on the device during procedure.There was no patient injury, medical intervention, or extended procedure time reported.

• Brand Name: NA
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS PHOENIX; 10232 s. 51st st.; phoenix AZ 85044
• MDR Report Key: 5995413
• Report Number: 0002090040-2016-00012
• Device Sequence Number: 434802
• Product Code: NLH
• UDI-Device Identifier: 00885825006679
• UDI-Public: 00885825006679
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2018
• Device Model Number: 401451
• Device Catalogue Number: 401451CO
• Device Lot Number: 2881817SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Initial Report FDA Received Date: 10/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1