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

Model Number	401904
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
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 was identified 17 cm from the distal tip; which is proximal to the transition point.The handle, steering knob, and electrodes appear to be intact.The device did not meet the curve specification nor 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 a bend proximal to the transition point as a result of mishandling subsequent to distribution, including shipping/storage conditions or improper manipulation of the catheter.The instructions for use (ifu) state: inspect the catheter for overall condition and physical integrity.Do not use the catheter if electrodes appear loose or if any damage is noted.If such problems exist, return the catheter and packaging to stryker sustainability solutions.Connect the catheter to the corresponding cable connector.Connect the cable to the correct electronic equipment for recording and/or sensing.Observe polarity of proximally located connector pins of the interface cable when connecting to the electronic equipment.Isolate any unused connector pins to reduce development of accidental current pathways to the heart.Follow a suitable electrophysiology study protocol.Do not autoclave catheter.Do not use for electrical ablation.Avoid excessive contact of handpiece with fluids, as this could adversely affect the electrical performance of the catheter.Diagnostic ep catheters are not recommended for long term pacing.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the catheter was 'too flimsy to manipulate'.It was removed and replaced.The catheter was flimsy and like a noodle when manipulated.There was no patient injury or medical intervention and extended procedure time length is unknown.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: 11016476
• Report Number: 0002090040-2020-00037
• Device Sequence Number: 10950880
• Product Code: NLH
• UDI-Device Identifier: 00885825007263
• UDI-Public: 00885825007263
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 08/31/2022
• Device Model Number: 401904
• Device Catalogue Number: 401904RR
• Device Lot Number: 4291987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1