BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIDGEPOINT MEDICAL, CTO SYSTEM

    MDR report key: 3022460 · Received March 25, 2013

    Report

    Report Number
    3007210311-2013-00001
    Event Type
    Other
    Date Received
    March 25, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BRIDGEPOINT MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE OF A CALCIFIED RCA IN WHICH THE BRIDGEPOINT SYSTEM; CONSISTING OF THE CROSSBOSS CATHETER, THE STINGRAY CATHETER AND THE STINGRAY GUIDE WIRE HAD BEEN USED THE PATIENT SUFFERED AN ARTERIAL PERFORATION REQUIRING PERICARDIALCENTESIS AND SURGERY TO REPAIR. THE CROSSBOSS CATHETER WAS USED WHICH TRACKED TO THE DISTAL VESSEL VIA THE SUBINTIMAL PLANE OVER A FIELDER XT GUIDEWIRE. THE CROSSBOSS CATHETER WAS REMOVED AND REPLACED WITH THE STINGRAY CATHETER AND GUIDEWIRE AND RE-ENTRY INTO THE TRUE LUMEN OF THE DISTAL RCA WAS ACHIEVED. THE STINGRAY GUIDEWIRE WAS REMOVED IMMEDIATELY POST "STICK" AND REPLACED WITH A PILOT 200 GUIDEWIRE, AFTER POSITIONING OF THE PILOT 200 GUIDEWIRE, STINGRAY CATHETER WAS REMOVED AND REPLACED WITH CORSAIR MICROCATHETER AND ACCESS TO THE PDA BRANCH OF THE RCA WAS THEN ATTEMPTED WITH THE PILOT 200 GUIDEWIRE. AFTER 3 MINUTES OF GUIDEWIRE MANIPULATION IT WAS FELT THAT THE PILOT 200 HAD FOUND THE OSTIUM OF THE PDA AND WAS TRACKING THE CORRECT PATH OF THE VESSEL. THE CORSAIR CATHETER WAS REMOVED AND REPLACED WITH A 2.0 DILATATION BALLOON AND PRE-DILATATION OF THE VESSEL IN PREPARATION FOR STENT REPLACEMENT WAS PERFORMED. IT WAS FELT AT THIS TIME TO DO INTRAVASCULAR ULTRASOUND OF THE VESSEL TO CONFIRM TRUE LUMEN PLACEMENT IN THE PDA AND TO DETERMINE CORRECT STENT SIZE FOR THE VESSEL. THE 2.0 BALLOON WAS REMOVED AND REPLACED WITH AN IVUS CATHETER WHICH WAS POSITIONED IN WHAT WAS FELT TO BE THE DISTAL PDA. IVUS SHOWED THAT THE CATHETER WAS NOT IN THE VESSEL ARCHITECTURE BUT IN THE PERICARDIUM. THE IVUS CATHETER WAS REMOVED AND ANGIOGRAPHY WAS PERFORMED WITH A GENTLE INJECTION OF CONTRAST, THIS SHOWED EXTRAVASATION OF THE CONTRAST INTO WHAT APPEARED TO BE ONE OF THE VENTRICAL CHAMBERS OF THE HEART. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND A PERICARDIALCENTESIS WAS PERFORMED WITH A SIGNIFICANT AMOUNT OF BLOOD REMOVED FROM THE PERICARDIAL SAC, A DRAIN WAS POSITIONED IN THE PERICARDIAL SAC AND THE PATIENT WAS BEING PREPPED FOR SURGERY TO REPAIR THE PERFORATION. PRIOR TO BEING TRANSPORTED TO THE SURGICAL SUITE, IT WAS REPORTED BY DR. (B)(6) THAT THE PATIENT HAD STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122346 BRIDGEPOINT MEDICAL, CTO SYSTEM CROSSBOSS/STINGRAY/STINGRAY GUIDEWIRE DQY BRIDGEPOINT MEDICAL INC. M2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention