WATCHDOGTM HEMOSTASIS VALVE
Received Aug 27, 2025 · Event occurred Jul 3, 2025
Report 2124215-2025-57368 · MDR key 22901456
Device
Generic name
Hemostasis Valve
Manufacturer
Boston Scientific CorporationModel number
750Catalog number
750
Lot number
0036718418
Product problems
- Device-Device Incompatibility
- Physical Resistance/Sticking
- Device-Device Incompatibility
- Physical Resistance/Sticking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE STENT FELL OFF AND HAD TO BE SNARED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A WATCHDOG HEMOSTASIS VALVE AND A SYNERGY STENT WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS DIFFICULT TO CROSS THE STENT THROUGH THE WATCHDOG. THE STENT FELL OFF AND HAD TO BE SNARED. THE DETACHED STENT WAS FULLY REMOVED FROM THE PATIENTS BODY AND THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC (BSC) DEVICE. THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Additional Manufacturer Narrative
H6: IMPACT CODES: CORRECTED.
Description of Event or Problem
IT WAS REPORTED THAT THE STENT FELL OFF AND HAD TO BE SNARED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A WATCHDOG HEMOSTASIS VALVE AND A SYNERGY STENT WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS DIFFICULT TO CROSS THE STENT THROUGH THE WATCHDOG. THE STENT FELL OFF AND HAD TO BE SNARED. THE DETACHED STENT WAS FULLY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC (BSC) DEVICE. THE PATIENT WAS STABLE AFTER THE PROCEDURE.