BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER

    MDR report key: 2856589 · Received December 3, 2012

    Report

    Report Number
    3007210311-2012-00008
    Event Type
    Death
    Date Received
    December 3, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BRIDGEPOINT MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN DISCUSSION AFTER THE PROCEDURE WITH (B)(6), VISITING PHYSICIAN AT THE PROCEDURE, DR. (B)(6) STATED THAT THE CAUSATION WAS DUE TO THE PROXIMAL BALLOON INFLATION AND WAS NOT (B)(6) DEVICES RELATED.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON A CTO LESION IN A HEAVILY CALCIFIED RCA IN WHICH THE CROSSBOSS HAD BEEN USED, THE PATIENT SUFFERED A PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND EPISODES OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION THAT REQUIRED RESUSCITATION. ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT EXPIRED AT APPROXIMATELY 1:00 AM ON (B)(6) 2012. THE PROCEDURE WAS BEING CONDUCTED VIA THE ANTEGRADE APPROACH ON A HEAVILY CALCIFIED RCA CTO LESION. THE CROSSBOSS CATHETER WAS PREPPED, USED AND TRACKED THROUGH THE CTO LESION REMAINING IN THE TRUE LUMEN OF THE ARTERY. THE CROSSBOSS CATHETER WAS REMOVED AND REPLACED WITH A BALLOON DILATATION CATHETER. INFLATIONS WERE PERFORMED WITH A 2.5 X 20 MM BALLOON DILATATION CATHETER (UNKNOWN ATM) FROM DISTAL TO PROXIMAL VESSEL AND TWO 2.5 MM STENTS WERE DEPLOYED IN THE MID TO DISTAL VESSEL. SUBSEQUENT ANGIOGRAPHY SHOWED THAT THE PROXIMAL VESSEL LUMEN WAS STILL NOT OPTIMAL AND THE DECISION WAS MADE TO DO A PRE-DILATATION OF THE PROXIMAL ARTERY WITH A 3.0 X 20 MM BALLOON DILATATION CATHETER AT 12 ATM. UPON DEFLATION OF THIS BALLOON A SIGNIFICANT PERFORATION OF THE RCA WAS NOTED AT THE AREA OF THE PROXIMAL CAP OF THE CTO LESION. THE PATIENT BECAME HEMODYNAMICALLY COMPROMISED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH SHOWED EXTRAVASATION INTO THE PERICARDIAL SAC AND PERICARDIAL TAMPONADE, THE DECISION WAS MADE AFTER VIEWING THE ECHOCARDIOGRAM RESULTS TO REVERSE ANTICOAGULATION THERAPY. THE PATIENT CONTINUED TO BECOME HEMODYNAMICALLY UNSTABLE AND SUFFERED EPISODES OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION THAT REQUIRED RESUSCITATION WITH INTUBATION. A PERICARDIOCENTESIS WAS PERFORMED WHICH RESULTED IN APPROXIMATELY 2 LITERS OF BLOOD BEING REMOVED FROM THE PERICARDIAL SAC. THE PATIENT CONTINUED TO BE UNSTABLE AND A SURGERY CONSULTATION WAS REQUESTED. AT THIS TIME 2 GRAFTMASTER STENTS WERE DEPLOYED IN THE PROXIMAL ARTERY. AN ECHOCARDIOGRAM WAS AGAIN PERFORMED AFTER THE PERICARDIOCENTESIS WHICH SHOWED THAT THE FLUID HAD BEEN CLEARED FROM THE PERICARDIAL SAC. A LEFT ATRIAL ASSIST DEVICE WAS PLACED AND THE PATIENT STABILIZED WITH A BP OF 110/70 AND A HEART RATE OF 80 IN SINUS RHYTHM. PATIENT WAS TRANSFERRED TO ICU AND EXPIRED AT APPROXIMATELY 1 AM ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER CROSSBOSS DQY BRIDGEPOINT MEDICAL, INC. M2000 BP20121010061

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R