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

Model Number	401443
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to the stryker sustainability solutions (b)(4) manufacturing facility through the collections process.The device was rejected during inline inspection.The device was found to be eligible for rejection for a wave issue.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 a bend as a result of mishandling, including shipping and storage conditions, subsequent to distribution from stryker.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 excessive torque, stretching, kinking and/or bending of catheter, as this may interfere with distal tip shaping or cause damage to internal electrode wires.Do not alter this device.The reported event will continue to be monitored through post-market surveillance.Device returned to incorrect location.
Event or Problem Description
It was reported, "during an atrial fibrillation ablation procedure, the resterilized catheter could no longer be advanced or retrieved in the right ventricle.Under x-ray the catheter appeared to be tied in a knot.The catheter was unable to be removed so cryoablation was continued.After the procedure a snare was used to help straighten the catheter.The catheter was removed with no adverse effects to the patient." there was no patient injury reported.No information was provided regarding extended procedure time.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: 11004397
• Report Number: 0002090040-2020-00035
• Device Sequence Number: 3814001
• Product Code: NLH
• UDI-Device Identifier: 00885825006617
• UDI-Public: 00885825006617
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: 401443
• Device Catalogue Number: 401443RR
• Device Lot Number: 4268751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/14/2020
• 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: Required Intervention