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

Catalog Number	401223
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Open or Remove Packaging Material (2922); Material Deformation (2976); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer was facing a few issues with the catheter.As reported, the catheter barely come out of the transparent sleeve, the shape is not as normal, they are more "wrinkled" than usual and don¿t keep their basic shape.There was no patient injury or medical intervention and extended procedure time reported was a few minutes.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
The investigation results confirm this incident no longer falls within mdr reportability requirements as it was determined it was not functional output ¿ioc-13: shear / friction force (deflection mechanism)2¿.The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, damage to the catheter shaft was identified.Inspection of the catheter shaft revealed material deformations (kink/ bends), measured from the catheter tip, the deformations were identified at 11.5, 25, 82, and 115 mm approximately.The device and tubing were straightened, the catheter was removed from its tubing with little-to-no resistance experienced.Additionally, removal of the catheter from its tubing included the removal of ancillary packaging components (blue clips).A calibrated steel ruler was used to identify the locations of the material deformations.As little-to-no resistance was experienced when removing the tubing from the device shaft, the customer's reported event of, "the catheter barely come out of the transparent sleeve" is considered to be not confirmed.However, as the device was identified for damage during re-inspection, the customer's reported event of, "the shape is not as normal" is considered to be confirmed.A review of the dhr supports that the device (including its packaging) 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 caused degradation of the device's anatomical structure.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.
Event or Problem Description
It was reported that the customer was facing a few issues with the catheter.As reported, the catheter barely come out of the transparent sleeve, the shape is not as normal, they are more "wrinkled" than usual and don¿t keep their basic shape.There was no patient injury or medical intervention and extended procedure time reported was a few minutes.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: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 20940698
• Report Number: 0002090040-2024-00025
• Device Sequence Number: 20866948
• Product Code: NLH
• UDI-Device Identifier: 00885825005818
• UDI-Public: 00885825005818
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K030026
• 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): 01/17/2025

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: 07/16/2026
• Device Catalogue Number: 401223
• Device Lot Number: 5391945
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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