MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHDOGTM HEMOSTASIS VALVE KIT

Model Number	161
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device caused an air introduction to the system.A watchdog hemostasis valve kit was selected for use.During the preparation, it was noted that the watchdog valve failed when attached to boston scientific cryo balloon.The irrigation port of the valve came loose which causing air introduction to the system.This did not impact the patient as it was not in the body at the time.
Event or Problem Description
It was reported that the device caused an air introduction to the system.A watchdog hemostasis valve kit was selected for use.During the preparation, it was noted that the watchdog valve failed when attached to boston scientific cryo balloon.The irrigation port of the valve came loose which causing air introduction to the system.This did not impact the patient as it was not in the body at the time.No patient complications were reported post procedure.It was further reported that the procedure was completed with another of the same device.

• Brand Name: WATCHDOGTM HEMOSTASIS VALVE KIT
• Common Device Name: HEMOSTASIS VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19034547
• Report Number: 2124215-2024-20242
• Device Sequence Number: 8120736
• Product Code: DTL
• UDI-Device Identifier: 08714729965770
• UDI-Public: 08714729965770
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K172453
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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 Model Number: 161
• Device Catalogue Number: 161
• Device Lot Number: 0032958965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2023
• 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
• Patient Sex: Unknown