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

Model Number	401932
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, a bend with twisted shaft material was identified approximately 10cm from the distal tip, which is distal to the transition point.A kink was identified 14cm from the distal tip, which is distal to the transition point.The stiffening bar on the interior of the catheter sheathing appeared to be bent and or twisted distal to the transition point.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The most likely root cause of the kinks distal to the transition point of the catheter is improper manipulation of the catheter during the procedure and/or excessive pressure exerted during navigation and manipulation of the catheter.The instructions for use (ifu) state: do not introduce the tip folded into the guiding sheath.Do not exert excessive pressure during placement of catheter if unknown resistance is encountered.Do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use.Avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the catheter was misshaped/broken.There was a minimal delay to replace the device.It was stated by the customer the doctor marked "possible patient harm" on his sheet.No additional details were provided as that was all the information the customer had.There was no medical intervention reported.These are commonly used devices that are readily available.

• 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: 6315884
• Report Number: 0002090040-2017-00001
• Device Sequence Number: 10894796
• Product Code: NLH
• UDI-Device Identifier: 00885825007355
• UDI-Public: (01)00885825007355(17)180929(10)3006884SH
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K052603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2017

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: 09/29/2018
• Device Model Number: 401932
• Device Catalogue Number: 401932CO
• Device Lot Number: 3006884SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 02/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1