BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER

    MDR report key: 2312351 · Received October 27, 2011

    Report

    Report Number
    3007210311-2011-00001
    Event Type
    Death
    Date Received
    October 27, 2011
    Date of Event
    September 21, 2011
    Report Date
    September 29, 2011
    Manufacturer
    BRIDGEPOINT MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K081130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN EFFORT TO UNDERSTAND AND ACCURATELY CHARCTERIZE BRIDGEPOINT MEDICAL DEVICE INVOLVEMENT, (B)(6) CONTACTED BOTH DR. (B)(6) {ON (B)(6) 2011 @ 5:20 PM (25 MINUTES)} AND VISITING (B)(6) ((B)(6) HOSPITAL) {ON (B)(6) 2011 @ 10:40 AM (10 MINUTES)} WHO ATTENDED THE CASE. BOTH ATTENDING PHYSICIANS AGREED THAT THE COMPLICATION WAS NOT ATTRIBUTED TO THE BRIDGEPOINT MEDICAL CROSSBOSS CATHETER OR ANY BRIDGEPOINT MEDICAL PRODUCT.

    Description of Event or Problem · 1

    THE DEATH OF A (B)(6) FEMALE PT WAS REPORTED BY DR. (B)(6). THE PT WAS BEING TREATED FOR A CHRONIC TOTAL OCCLUSION OF THE RCA WITH THE BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, STINGRAY CATHETER AND STINGRAY GUIDEWIRE BEING USED TO SUCCESSFULLY CROSS THE OCCLUSION. DURING THE INITIAL ADVANCEMENT OF THE CROSSBOSS CATHETER, THE CATHETER WAS THOUGHT TO HAVE CANNULATED A SIDE BRANCH IN THE PROXIMAL PORTION OF THE VESSEL. A CONFIANZA PRO 12 GUIDEWIRE WAS USED TO RE-DIRECT THE CROSSBOSS CATHETER AND IT WAS ADVANCED TO THE DISTAL VESSEL BEYOND THE CTO IN THE SUBINTIMAL SPACE. THE CROSSBOSS CATHETER WAS REMOVED AND THE STINGRAY CATHETER WAS ADVANCED OVER THE WIRE TO THE DISTAL TARGET. RE-ENTRY INTO THE TRUE LUMEN WAS SUCCESSFUL WITH THE STINGRAY GUIDEWIRE. THE BRIDGEPOINT MEDICAL DEVICES WERE EXCHANGED AND THE VESSEL WAS THEN DILATED WITH A CONVENTIONAL BALLOON CATHETER. A RADIOGRAPHIC CONTRAST (DYE) INJECTION WAS DELIVERED TO THE PROXIMAL RCA. A SMALL PERFORATION WAS OBSERVED IN THE PROXIMAL VESSEL IN PROXIMITY TO THE AREA OF CROSSBOSS CATHETER SIDE BRANCH CANNULATION AND CONFIANZA REDIRECTION. NO ACTION WAS TAKEN TO RESOLVE THE PERFORATION AS THE MAGNITUDE OF THE DYE BLUSH WAS NOT SIGNIFICANT ENOUGH TO WARRANT INTERVENTION. TWO BARE METAL STENTS WERE DEPLOYED IN THE DISTAL VESSEL. DURING STENT DEPLOYMENT THE PERFORATION RESOLVED AS SEEN VIA ANGIOGRAPHY. AN ECHOCARDIOGRAM WAS PERFORMED AND A SMALL PERICARDIAL EFFUSION WAS OBSERVED SUGGESTING THE PERFORATION WAS NOT SIGNIFICANT, HAD SEALED AND WAS NOT BLEEDING INTO THE PERICARDIAL SAC. A THIRD STENT WAS DEPLOYED AND A DYE INJECTION WAS PERFORMED. THE STENT DEPLOYMENT CREATED A SIGNIFICANT PERFORATION WITH FREE FLOWING DYE INTO THE PERICARDIAL SAC. THE LOCATION OF THIS SECOND AND LARGER PERFORATION WAS NOT IN THE SAME LOCATION AS THE FIRST SMALL PERFORATION. THE PT'S BLOOD PRESSURE DROPPED DUE TO CARDIAC TAMPONADE. HEPARINIZATION WAS REVERSED USING PROTAMINE AND PERICARDIOCENTESIS WAS PERFORMED. A TOTAL OF 1.5 LITERS OF BLOOD WAS DRAWN FROM THE PT. THE PT'S BLOOD PRESSURE QUICKLY RETURNED TO NORMAL. A COVERED STENT WAS DEPLOYED SPANNING THE SECTION OF STENT - INDUCED PERFORATION THUS SEALING THE PERFORATED ARTERY. IMMEDIATELY AFTER THE PROCEDURE THE PT SUFFERED A SIGNIFICANT STROKE. THE PT NEVER RECOVERED AND DIED FOUR DAYS POST-PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death