MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHDOGTM HEMOSTASIS VALVE

Model Number	750
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Air Embolism (1697); Insufficient Information (4580)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.Good faith effort attempts were made to try and retrieve product and event details, but further information was unable to be obtained.
Event or Problem Description
It was reported that valve issues occurred causing air embolism and patient instability.A watchdog hemostasis valve was selected for use.During the procedure, valve issues were encountered, air entered the system and the vessel, which created some initial patient instability.It was noted that flushing and waiting resolved the issue.The remainder of the procedure was carried out successfully using an alternate device and the patient was fine.No further patient complications were reported as a result of this event.

• Brand Name: WATCHDOGTM HEMOSTASIS VALVE
• Common Device Name: HEMOSTASIS VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22146753
• Report Number: 2124215-2025-32476
• Device Sequence Number: 12672312
• Product Code: DTL
• UDI-Device Identifier: 08714729965763
• UDI-Public: (01)08714729965763
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 750
• Device Catalogue Number: 750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/04/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown