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

Model Number	D134302
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
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, no relevant visible damage was detected, the catheter shaft, handle, eco connector, connector pins, and electrodes appeared to be intact.During functional inspection, the deflection knob was deflected.During this articulation, the deflection knob was observed to move without any traction or feedback force within the handle.Additionally, when the device was deflected, the catheter distal tip did not deflect or move in the corresponding direction.It is likely that this may have contributed to the reported event, as a compromised deflection knob is likely to affect how the device bends or deflects.The functional inspection indicated that the complaint is confirmed for the reported failure mode.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the likely root cause as a result of mishandling subsequent to distribution, including shipping and storage conditions or improper manipulation of the device.The instructions for use (ifu) state: electrical performance could be affected if the proximal handle, pig tail or cable connector are immersed in fluids.To avoid potential damage to anatomical structures, do not attempt to pull the catheter, or withdraw it into the sheath, with the loop in a contracted position.To minimize tension applied to the nitinol structure, the loop should be fully relaxed (handle grip rotated fully to the left).Do not introduce the catheter¿s tip folded into the guiding sheath.Place the catheter by rotating (or torquing) the shaft in a clockwise motion only to reduce the risk of entrapping cardiac structures in the mapping electrode portion of the catheter.When not in regions intended for mapping, manipulate the catheter with the loop in the fully expanded (i.E.25 mm diameter) position to further decrease the risk of entrapping cardiac structures.Do not use in the proximity of magnetic resonance imaging (mri) equipment because the mri equipment may induce movement of the catheter, resulting in perforation.Until used, the catheter should be stored in its original packaging and in a cool, dry place.Prior to connecting and attempting to operate the catheter, read and understand all accessory operating instructions and these instructions for use.Cardiac catheterization procedures should be performed by appropriately trained personnel in a fully equipped electrophysiology laboratory.Inspect the sterile packaging and catheter prior to use.Do not use if the package is open or damaged.The standard transeptal procedure should be followed during mapping when moving the catheter from the right atrium to the left atrium.Prior to mapping, the physician should ensure that the intracardiac signals are recorded by all of the electrodes on the loop of the catheter.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the catheter does not bend.There was no patient injury, medical intervention, or extended procedure time reported.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: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 24634382
• Report Number: 0002090040-2026-00005
• Device Sequence Number: 8596119
• Product Code: NLH
• UDI-Device Identifier: 00885825011697
• UDI-Public: 00885825011697
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 5430193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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