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

Model Number	402004
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Open or Remove Packaging Material (2922); Mechanical Jam (2983)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the quad catheter are not sliding out of their packaging tubes very well.As reported, were getting stuck to the point that the curve on th end of the catheters are being straightened out.In particular, the crd-2 are most affected.No information was provided regarding patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported the quad catheter are not sliding out of their packaging tubes very well.As reported, were getting stuck to the point that the curve on the end of the catheters are being straightened out.In particular, the crd-2 are most affected.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Updated d4 "model #" from 401443 to 402004.Updated d4 "gtin" from (b)(4).The investigation results confirm this incident no longer falls within mdr reportability requirements as it was determined that the reported failure was not confirmed.The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, its racetrack tubing partially detached from the catheter.Additionally, the distal tip-protector was not included in the return and the tubing blue-clips were found partially detached from the racetrack.Upon visual inspection of the received complaint device and packaging, the catheter was removed from its tubing with little-to-no resistance experienced.Furthermore, no relevant visible damage was observed to the device.The catheter shaft and distal tip appeared to be intact.The results of the investigation determined that the reported failure mode is not 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 improper removal of the device's packaging, which may cause degradation of the device's anatomical structure if not removed correctly.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.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.

• 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: 21027503
• Report Number: 0002090040-2024-00031
• Device Sequence Number: 21081419
• Product Code: NLH
• UDI-Device Identifier: 00885825007744
• UDI-Public: 00885825007744
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K012708
• 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,Followup
• Report Date (Section B): 03/10/2025

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 Expiration Date: 08/02/2026
• Device Model Number: 402004
• Device Catalogue Number: 402004
• Device Lot Number: 5399462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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