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

Model Number	401904
Medical Device Problem Codes	Poor Quality Image (1408); 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
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.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the complaint device was not returned for evaluation, the customer's reported event could not be confirmed, and a conclusive root cause could not be determined.A review of the device history record (dhr) could not be performed as the device's lot and serial numbers were not reported.Stryker procedure(s) supports that the device was unlikely to have been released from stryker sustainability solutions with the reported failure mode.The reported event could be attributed to: user error (including user technique and methods).User anticipation/ expectation of device performance.Connection error (including the complete contact of connector-pins to corresponding receptors).Ancillary equipment error (including all other equipment in proximity of the device that may have contributed to the malfunction).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.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.Do not insert or withdraw the catheter without straightening the catheter tip.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

• 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: 23870697
• Report Number: 0002090040-2025-00049
• Device Sequence Number: 14590704
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• 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): No
• 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