MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC WATCHDOG VALVE; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Lot Number	32958965
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific watchdog valve failed when attached to boston scientific cryo balloon.The irrigation port of the valve came loose during prep, causing air introduction to the system.This did not impact the patient as it was not in the body at the time.This has happened in two previous cases.The plastic threads will strip easily and should not be used with this system set up.

• Brand Name: BOSTON SCIENTIFIC WATCHDOG VALVE
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18782497
• Report Number: MW5151977
• Device Sequence Number: 7757994
• Product Code: DTL
• UDI-Device Identifier: 08714729965794
• UDI-Public: 08714729965794
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

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 Expiration Date: 11/29/2025
• Device Lot Number: 32958965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRYO BALLOON.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White