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

Model Number	320002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed a kink 15 cm from the distal tip.The distal tip where the kink is, shows no puncture to the outer coating, and no strings were extruding internally from the catheter.As a result of the kink, the distal tip delaminated and appears like a string when deflected.The handle, push/pull thumb slide, and electrodes appeared to be intact.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 is mishandling subsequent to distribution, including shipping/storage conditions or improper 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 ep catheter was inside the heart and the catheter broke.Upon removal, it was reported there was a white string coming out of the tear in the region where the catheter bends.There was no material separation.The catheter was easily removed and replaced to successfully complete the procedure.There was no patient injury or medical intervention and extended procedure time reported was 30 seconds.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: 9821806
• Report Number: 0002090040-2020-00011
• Device Sequence Number: 1767368
• Product Code: NLH
• UDI-Device Identifier: 00885825004125
• UDI-Public: 00885825004125
• Combination Product (Y/N): N
• Initial Reporter Country: IL
• PMA/510(K) Number: K030187
• 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): 03/11/2020

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: 11/07/2021
• Device Model Number: 320002
• Device Catalogue Number: 320002RR
• Device Lot Number: 4061485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2020
• Initial Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 32 YR