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

Model Number	7003DRR
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was defective.There was no patient injury and the complainant is not aware of any 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 visual inspection of the received complaint device, three kinks were identified.The first kink was located 2.4 cm from the distal tip, the second kink was located 6.2 cm from the distal tip, and finally the third kink was located at 11.2 cm from the distal tip.The first two kinks were found to be distal to the transition point and the third kink was found to be proximal from the transition point.The connector and electrodes appeared to be intact.The device was evaluated and the device did not meet the curve or planarity specification.Additional functional inspection was performed via inline testing.Given the reported event, per re-inspection documentation, the device met all electrical test criteria, however, failed for 'wave', reject code 46, confirming the visual inspection findings.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 causes is mishandling subsequent to distribution, including shipping/storage conditions or improper manipulation of the catheter.The instructions for use (ifu) state: 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.Connect the catheter to the corresponding cable connector.Connect the cable to the correct electronic equipment for recording and/or sensing.Observe polarity of proximally located connector pins of the interface cable when connecting to the electronic equipment.Isolate any unused connector pins to reduce development of accidental current pathways to the heart.Follow a suitable electrophysiology study protocol.Do not autoclave catheter.Do not use for electrical ablation.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.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: 21572190
• Report Number: 0002090040-2025-00027
• Device Sequence Number: 8280309
• Product Code: NLH
• UDI-Device Identifier: 00885825008710
• UDI-Public: 0885825008710
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K052414
• 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): 03/11/2025

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 Model Number: 7003DRR
• Device Catalogue Number: 7003D
• Device Lot Number: 4362321SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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