BEUDAMED
    FDA Adverse Event Other Summary report: N

    CROSSBOSS CATHETER/STINGRAY CATHETER AND GUIDEWIRE

    MDR report key: 2858042 · Received November 21, 2012

    Report

    Report Number
    3007210311-2012-00007
    Event Type
    Other
    Date Received
    November 21, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BRIDGEPOINT MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POST PROCEDURE IN DISCUSSION WITH (B)(6), DR (B)(6) STATED THAT HE FELT THE CAUSATION OF THE PERFORATION WAS THE PROXIMAL BALLOON INFLATIONS IN THE PROXIMAL ARTERY AND THE BRIDGEPORT SYSTEM WAS NOT PART OF THE CAUSATION. DR (B)(6) ALSO CONTACTED (B)(6) ON (B)(6) 2012 AND STATED THAT THE PATIENT WAS DOING WELL, HAD BEEN EXTUBATED, AND HAD NO CARDIAC ENZYME "BUMPS' OVERNIGHT AND SHOULD BE DISCHARGED TO HOME WITHIN 2 DAYS POST PROCEDURE.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON A CTO LOCATED IN THE RCA IN WHICH THE BRIDGEPOINT SYSTEM WAS USED, THE PATIENT SUFFERED A PERFORATION THAT REQUIRED A PERICARDIOCENTESIS, DURING WHICH THE PATIENT SUFFERED THREE EPISODES OF VENTRICULAR TACHYCARDIA, WHICH REQUIRED CARDIOVERSION TO CONVERT BACK TO SINUS RHYTHM. THE PROCEDURE WAS FIRST ATTEMPTED VIA THE RETROGRADE APPROACH, WHICH THE PATIENT COULD NOT TOLERATE AND WAS SWITCHED TO AN ANTEGRADE APPROACH. THE AORTIC ROOT WAS SMALL IN DIAMETER AND THE TAKEOFF OF THE RCA WAS NOT OPTIMAL A 7 FR GUIDECATHETER WAS USED. A GUIDEWIRE WAS USED TO PROVE THE VESSEL TO THE PROXIMAL CAP OF THE LESION, THE CROSSBOSS CATHETER WAS INTRODUCED AND TRACKED VIA A SUBINTIMAL PATHWAY TO THE PRE-DETERMINED RE-ENTRY SITE DISTAL TO THE LESION. THE CROSSBOSS CATHETER WAS REMOVED AND THE STINGRAY CATHETER WAS INTRODUCED AND POSITIONED AT THE RE-ENTRY SITE. DURING A GUIDEWIRE EXCHANGE FOR THE STINGRAY GUIDEWIRE, THE GUIDECATHETER "POPPED" OUT OF THE OSTIUM AND RE-ENTRY POSITION WAS LOST. THE GUIDECATHETER WAS REPOSITIONED IN THE OSTIUM OF THE VESSEL AND A NEW CROSSBOSS CATHETER OVER A GUIDEWIRE WAS INTRODUCED AND TRACKED WITHOUT DIFFICULTY BACK TO THE RE-ENTRY POSITION, THE CROSSBOSS CATHETER WAS REMOVED AND REPLACED WITH THE STINGRAY CATHETER. THE STINGRAY CATHETER WAS POSITIONED AT THE RE-ENTRY SITE AND INFLATED TO 3 ATM, THE STINGRAY GUIDEWIRE WAS USED TO RE-ENTER TO THE VESSEL TRUE LUMEN. THE STINGRAY CATHETER AND GUIDEWIRE WAS REPLACED WITH A 2.5 MM DILATATION BALLOON CATHETER AND A SPRING-COILED GUIDEWIRE. MULTIPLE BALLOON DILATATIONS WITH THE 2.5 MM BALLOON CATHETER (ATM NOT REPORTED) WAS PERFORMED FROM THE DISTAL RCA TO THE PROXIMAL RCA. AT THIS TIME THE DECISION WAS MADE TO PERFORM A SMALL ANTEGRADE INJECTION TO ASSESS THE VESSEL, THIS SHOWED A STAIN OUTSIDE THE ARTERIAL ARCHITECTURE. STENTS WERE THEN POSITIONED AND DEPLOYED IN THE PROXIMAL VESSEL. ANTEGRADE INJECTION AT THIS TIME SHOWED THAT THE STAIN HAD NOT DISBURSED AND A SMALL JET OF CONTRAST WAS NOTED. AN ATTEMPT TO DEPLOY A COVERED STENT AT THE PERFORATION WAS NOT SUCCESSFUL AND THE STENT BECAME STUCK IN THE 7 FR GUIDECATHETER WHICH RESULTED IN THE SYSTEM BEING REMOVED AND REPLACED WITH AN 8 FR GUIDECATHETER. DURING POSITIONING OF THE 8 FR GUIDECATHETER THE PATIENT'S BLOOD PRESSURE AND HEART RATE DECREASED AND THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. ANTICOAGULATION THERAPY WAS REVERSE AND A 2.5 MM DILATATION CATHETER WAS MADE TO PERFORM A PERICARDIOCENTESIS, WHICH WAS ACCOMPLISHED WITH DIFFICULTY AND DURING WHICH TIME THE PATIENT EXPERIENCED 3 EPISODES OF VENTRICULAR TACHYCARDIA WHICH REQUIRED CARDIOVERSION TO COVERT BACK TO A SINUS RHYTHM AND THE PATIENT TO BE INTUBATED. ONCE THE PERICARDIOCENTESIS WAS COMPLETED AND A DRAIN WAS POSITIONED THE PATIENT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSBOSS CATHETER/STINGRAY CATHETER AND GUIDEWIRE CROSSBOSS/STINGRAY SYSTEM DQY BRIDGEPOINT MEDICAL, INC. M2000/M-100/M3012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention