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

Model Number	401932RR
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, the catheter shaft was observed to be damaged.Inspection of the device shaft revealed a knot, located (approximately) 36 cm from the catheter distal tip.The knot was then untied, revealing a section of shaft deformations between 36 cm - 45 cm, compromising the catheter's structural integrity and electrical quality.Calibrated steel ruler sr-032 was used to identify the location of the material deformations.No further relevant visible damage was detected.The hypertronics connector(s), handle/ body, deflection mechanism, and electrodes appeared to be intactt.As signs of catheter misuse was identified during inspection, a functional evaluation of the complaint device could not be performed as damage to the catheter's electrical qualities (i.E., connectors, shaft, electrodes and internal wiring) is likely to affect the device's electrical performance and it's intended use.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the reported event could be attributed to: user error (including user technique and methods).User anticipation/ expectation of the device's performance.Connection error (including the complete contact of the pins to receptors).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.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.Compatibility: ep catheters are connected to standard electronic recording equipment using appropriate cable connectors.Use the appropriate interface cables for the reprocessed ep catheter being utilized.Temporary pacing connections: ¿distal¿ negative ( - ) electrode jack to negative ( - ) terminal of external pulse generator.Positive (+) electrode jack to positive (+) terminal of external pulse generator.Shield remaining electrode jacks.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 just cut tip - broken.The complainant is not aware of any patient injury, medical intervention, or extended procedure time.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: 21562561
• Report Number: 0002090040-2025-00022
• Device Sequence Number: 15757056
• Product Code: NLH
• UDI-Device Identifier: 00885825007355
• UDI-Public: 00885825007355
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/10/2025

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: 08/21/2025
• Device Model Number: 401932RR
• Device Catalogue Number: 401932RR
• Device Lot Number: 5157865SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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