MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHDOGTM HEMOSTASIS VALVE

Model Number	750
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood loss occurred.A watchdog hemostasis valve was selected for use.During the procedure, it was noted that the watchdog was leaking an excessive amount of blood.The tubing was replaced three times and the leaking was not resolved.A new watchdog was selected and there was no leaking.The procedure was completed with another of same device.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was visually and microscopically examined.There was blood present in the body of the y-adapter valve.All connection points, and the plunger were inspected and on the luer port there was a stress crack.The cracked luer port indicates there was force during device use which could have occurred during preparation of the device, procedural use.The valve was flushed to remove the excess blood from the device.The device was functionally tested for leaks in the other connection points to the valve.The luer port was connected to an inflation device filled with water to functionally test the device.The plunger was verified to be in the lock position, and the guide catheter was suppressed to close off and fully test for further leaks at minimal pressure.The crack in the luer port was the only leaking point to the valve and there were no further damages or irregularities to the device.The plunger was put in the open position and the guide catheter was not suppressed to ensure correct flow on both ends.Product analysis confirmed the reported event, as the luer port had a stress crack which indicates force during device use.Ifu states: do not overtighten the connections as it may damage the device.
Event or Problem Description
It was reported that blood loss occurred.A watchdog hemostasis valve was selected for use.During the procedure, it was noted that the watchdog was leaking an excessive amount of blood.The tubing was replaced three times and the leaking was not resolved.A new watchdog was selected and there was no leaking.The procedure was completed with another of same device.No further patient complications were reported.

• Brand Name: WATCHDOGTM HEMOSTASIS VALVE
• Common Device Name: HEMOSTASIS VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15019143
• Report Number: 2134265-2022-07904
• Device Sequence Number: 14993098
• 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): 08/26/2022

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: 04/04/2024
• Device Model Number: 750
• Device Catalogue Number: 750
• Device Lot Number: 0029168292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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