MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHDOGTM HEMOSTASIS VALVE

Model Number	750
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817); Ventricular Fibrillation (2130)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that air embolism occurred requiring intervention.A watchdog hemostasis valve was selected for a percutaneous coronary intervention procedure.During the procedure, an air embolism was introduced via the guide catheter.It was noted that the cause is related to the watchdog device.Consequently, the patient had st elevation and may have gotten a little sick but was ultimately fine.Code strategies were executed, and the patient was successfully revived from complications.The patient was admitted to the hospital beyond standard of care.The patient fully recovered, and the procedure was successfully completed using original method and/or device.
Event or Problem Description
It was reported that air embolism occurred requiring intervention.A watchdog hemostasis valve was selected for a percutaneous coronary intervention procedure.During the procedure, an air embolism was introduced via the guide catheter.It was noted that the cause is related to the watchdog device.Consequently, the patient had st elevation and may have gotten a little sick but was ultimately fine.Code strategies were executed, and the patient was successfully revived from complications.The patient was admitted to the hospital beyond standard of care.The patient fully recovered, and the procedure was successfully completed using original method and/or device.It was further reported that the patient sustained an air embolism that resulted in ventricular fibrillation.The patient was resuscitated successfully, admitted to the hospital for follow up care and discharged from the hospital in stable condition.

• 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: 20800656
• Report Number: 2124215-2024-73765
• Device Sequence Number: 7809799
• Product Code: DTL
• UDI-Device Identifier: 08714729965763
• UDI-Public: 08714729965763
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 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: 11/07/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/19/2025
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown