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

Model Number	401904
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the catheter had a curve on the wire which created a kink.As reported, staff were not able to cannulate the coronary sinus.The device came out the box with the issue and a new non-reprocessed replacement was used.There was no patient injury or medical intervention and extended procedure time reported was ten minutes.These are commonly used devices that are readily available.
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 device handle, steering dial, shaft, and electrodes appeared to be intact.The device did not meet the curve or planarity specification.The inspection results determined that the complaint is partially confirmed for the reported failure mode.As no relevant visible damage was observed to the catheter shaft, the customer's reported event of, ".Catheter had a curve on the wire which created a kink", is considered to be not confirmed.However, as the device failed curve specification during re-inspection, the reported failure mode is considered to be confirmed.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 device's curve shape.User expectation of the device's ability to deflect or steer.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.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.

• 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: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 21733476
• Report Number: 0002090040-2025-00029
• Device Sequence Number: 18299218
• 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): 03/31/2025

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: 5443038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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