MAUDE Adverse Event Report: STRYKER-ENDOSCOPY PHOENIX USA; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	D087031
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that following a pfa procedure, a pericardial effusion occurred which required surgery to repair the perforation.The procedure had gone well, pvi to find a his electrogram and pace in the right ventricle (rv) with a good outcome from the pvi point.A few hours post-procedure while in recovery, a pericardial effusion was diagnosed.Surgery was performed to repair the perforation in the right atrium.As reported, the patient was stable and recovering in the icu.The physician thinks the perforation may have been caused by the viewflex ice catheter which was reprocessed by stryker.There was no other patient injury or medical intervention reported and no extended procedure time was reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the device's lot and serial numbers were not reported.Stryker procedure(s) support(s) that the device was unlikely to have been released from stryker with the reported failure mode.The reported event could be attributed to mishandling subsequent to distribution, including shipping and storage conditions or improper manipulation of the device.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported that following a pfa procedure, a pericardial effusion occurred which required surgery to repair the perforation.The procedure had gone well, pvi to find a his electrogram and pace in the right ventricle (rv) with a good outcome from the pvi point.A few hours post-procedure while in recovery, a pericardial effusion was diagnosed.Surgery was performed to repair the perforation in the right atrium.As reported, the patient was stable and recovering in the icu.The physician thinks the perforation may have been caused by the viewflex ice catheter which was reprocessed by stryker.There was no other patient injury or medical intervention reported and no extended procedure time was reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• 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: 22383928
• Report Number: 0002090040-2025-00034
• Device Sequence Number: 21096270
• Product Code: OWQ
• UDI-Device Identifier: 07613327376067
• UDI-Public: 07613327376067
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K231621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: D087031
• Device Catalogue Number: D087031
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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