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

Model Number	402004
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Abdominal Pain (1685); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion requiring cardiac surgery to close the effusion and stabilize the patient occurred during a redo supraventricular tachycardia ablation procedure.As reported, an ablation catheter was used to ablate one area then it was decided to go transseptal and the patient reported abdominal discomfort.The ice catheter was inserted into the right atrium which revealed a large effusion.Ultrasound measured the effusion and a pericardiocentesis was performed and protamine was administered.The perforation was located in the right ventricle which was noted to be very thin as the sutures used to close the perforation were tearing through the tissue.As reported, the physician felt the perforation was caused by a diagnostic catheter reprocessed by stryker.The patient is reported to be recovering well and has since been discharged.Per the stryker sales representative, the customer contact stated it is unknown if ablation catheter, cs catheter or rv catheter caused the effusion.After cardiac surgery to stop the bleed, it was determined the area of the heart had paper thin tissue along with patient history of being on anti-coagulants creating a challenging patient anatomy.There was no other patient injury or medical intervention intervention reported and there was no extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.The customer contact stated the device is unable to be returned.As the device was not returned to stryker sustainability solutions, evaluation was unable to be performed.No device information was reported and the customer did not report lot # or serial # information.Therefore, the device history record (dhr) was unable to be verified.As the complaint device was not returned for evaluation, a conclusive root cause could not be determined.Therefore, the reported event is likely attributed to mishandling subsequent to distribution, including shipping and storage conditions or improper manipulation of the device.Stryker procedure(s) support(s) that the device was unlikely to have been released from stryker with the reported failure mode.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.Do not insert or withdraw the catheter without straightening the catheter tip.Personnel handling ep catheters should wear protective gloves.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.Should the device become available for return, the investigation will be reopened.

• 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: 21518468
• Report Number: 0002090040-2025-00012
• Device Sequence Number: 18531943
• Product Code: NLH
• UDI-Device Identifier: 00885825007744
• UDI-Public: 00885825007744
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K012708
• 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): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 402004
• Device Catalogue Number: 402004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown