MAUDE Adverse Event Report: STRYKER-ENDOSCOPY PHOENIX USA; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	401932
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the complaint device was received in a small recycled box with the curve/steering collar halfway deflected.No relevant visible damage was observed, the catheter connectors, extension wires, handle, steering mechanism, and electrodes appeared to be intact.During functional inspection, the catheter deflected smoothly when the steering mechanism was actuated, indicating proper steering function.However, during articulation, when the catheter was deflected back and forth, the distal tip was observed to deflect further back than the catheter's original undeflected position.The device was evaluated.The device met the planarity specification, but failed the curve specification likely because the catheter's deflection began from a position further back than the intended starting alignment, reducing its ability to achieve the specified curve.The functional inspection results determined that the complaint is confirmed for the reported failure mode.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 attributed to a curve failure as a result of mishandling subsequent to distribution, including shipping and storage conditions or improper manipulation of the device.The instructions for use (ifu) state: - do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use.- do not alter this device.- inspect the packaging and catheter for damage or defects prior to 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.- avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters.Handle catheter with care to avoid improper electrical functioning.- 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.- do not insert or withdraw the catheter without straightening the catheter tip.- this device should only be used with equipment that complies with international safety standards.- this device should not be used with magnetic resonance imaging (mri) systems.- use fluoroscopic guidance during catheter positioning.Storage and handling: - prior to use, store reprocessed ep catheters in a cool, dry, dark place.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the device did not steer tight enough by the physician.As reported, the device had multiple attempts to navigate femoral vein to cs that were unsuccessful.Ice was introduced to help guide the device to the proper location.Attempts were unsuccessful.Upon replacement with another stryker duadeca, access to the cs was gained upon the first attempt.The device was replaced with a stryker device.There was no patient injury or medical intervention and extended procedure time reported was 3-5 minutes as access was attempted and replacement was introduced.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STRYKER-ENDOSCOPY PHOENIX USA; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer (Section G): STRYKER-ENDOSCOPY PHOENIX USA; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer Contact: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 23751090
• Report Number: 0002090040-2025-00045
• Device Sequence Number: 5854524
• Product Code: NLH
• UDI-Device Identifier: 00885825007355
• UDI-Public: 00885825007355
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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
• Device Model Number: 401932
• Device Catalogue Number: 401932
• Device Lot Number: 5548641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown