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

Model Number	81531
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed a bend 11 cm from the distal tip.The handle, steering knob, and electrodes appeared to be intact.The device did not meet the curve specification.The device did not meet the planarity specification.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 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 when the physician tested the ep catheter curl before introducing it into the patient's body, it had a strange curve proximal.It was reported there was an extra curve proximal to the primary intended curve.There were no noted kinks or bends in body of catheter.There was no patient injury, medical intervention, or extended procedure time 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: 10380549
• Report Number: 0002090040-2020-00028
• Device Sequence Number: 1730187
• Product Code: NLH
• UDI-Device Identifier: 00885825010157
• UDI-Public: 00885825010157
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112232
• 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): 08/07/2020

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: 08/27/2020
• Device Model Number: 81531
• Device Catalogue Number: 81531RR
• Device Lot Number: 3666694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 58 YR