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

Model Number	401261
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was faulty as the curve and deflection were not good.The complainant is not aware of any patient injury, medical intervention, or extended procedure time.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, damage to the distal tip, curve, and shaft was observed.A wave measured from the catheter tip to 37 cm of the device shaft, affecting the catheter jsn curve.Additionally, the device did not form a curve consistent with the curve reference specification.The results of the investigation determined that the reported issue was confirmed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause is damage to the catheter shaft resulting in deformation of the device's fixed curve due to mishandling subsequent to distribution, including shipping/storage conditions or improper manipulation of the catheter.The instructions for use (ifu) state: - ep catheters should be used only by or under the supervision of an appropriately trained physician using proper procedures and techniques.- do not exert excessive pressure during placement of catheter if unknown resistance is encountered.- do not autoclave catheter.- do not introduce the tip folded into the guiding sheath.- 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.- do not insert or withdraw the catheter without straightening the catheter tip.- inspect the catheter for overall condition and physical integrity.Do not use the catheter if electrodes appear loose or if any damage is noted.If such problems exist, return the catheter and packaging to stryker sustainability solutions.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: 17509927
• Report Number: 0002090040-2023-00011
• Device Sequence Number: 14836643
• Product Code: NLH
• UDI-Device Identifier: 00885825005894
• UDI-Public: 00885825005894
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/11/2023

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: 03/02/2025
• Device Model Number: 401261
• Device Catalogue Number: UNK_SUS
• Device Lot Number: 5013900SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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