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

Model Number	401904
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 no relevant visible damage was observed.The catheter connectors, extension wires, shaft, handle, steering mechanism, and electrodes appeared to be intact.The device met the planarity and curve specification.The device was submitted to in-line testing and the device met all relevant test criteria.The inspection results determined that the complaint is not 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: - user error (including user technique and methods).- user expectation/anticipation of deflection feedback force - connection error (including the complete contact of pins to receptors).- ancillary equipment error (including all other equipment in proximity of the complaint device that may have contributed to the malfunction).The instructions for use (ifu) state: - 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.- standard electrical grounding precautions should be observed when using electrical recording or stimulation equipment.- 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 there was an issue with the livewire duodeca catheter.The pins did not have signal and the catheter was difficult to steer and position properly.As reported, this occurred during an afib ablation and added to the fluoro time and the time the patient was under general anesthesia, affecting both the patient and the staff.The catheter was replaced with an oem device.There was no patient injury or medical intervention and extended procedure time reported was the time of grabbing the oem device and using that device.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: 23870700
• Report Number: 0002090040-2025-00050
• Device Sequence Number: 4552686
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: 401904
• Device Catalogue Number: 401904
• Device Lot Number: 5545163SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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