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

Model Number	401904
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.Multiple attempts were made for additional information, including to inquire about device return, however the facility did not provide additional information.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributable to: user error (including user technique and methods).User expectation of the device's steering ability.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.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported during an atrial fibrillation ablation procedure, the catheter got stuck in the right ventricular apex while advancing to the coronary sinus causing some tricuspid regurgitation.A sheath had to be inserted to remove the catheter.The medwatch form selected "other serious (important medical events)", however no further details were provided from the customer about the event.Multiple attempts were made for additional information, however none were provided.There were no adverse consequences 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: 10590447
• Report Number: 0002090040-2020-00030
• Device Sequence Number: 3144021
• Product Code: NLH
• UDI-Device Identifier: 00885825007263
• UDI-Public: 00885825007263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: 401904
• Device Catalogue Number: 401904RR
• Device Lot Number: 4166411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR