BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1671899 · Received May 3, 2010

    Report

    Report Number
    2134265-2010-01974
    Event Type
    Death
    Date Received
    May 3, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4).

    Additional Manufacturer Narrative · 1

    UPDATED FIELDS: WEIGHT, DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY. (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A VESSEL PERFORATION AND SUBSEQUENT DEATH OCCURRED. THE LESION WAS LOCATED IN THE HIGHLY CALCIFIED BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY AND DIAGONAL. FIRST, THE PHYSICIAN ATTEMPTED TO CRACK THE CALCIFICATION WITH AN UNSPECIFIED NONCOMPLIANT BALLOON, INFLATED TO BETWEEN 20-25 ATMS. THEN, THE PHYSICIAN ADVANCED THE ROTABLATOR ROTALINK PLUS 1.5MM BURR AND BEGAN ABLATION. HOWEVER, THE BURR BECAME "BOGGED DOWN" AND THEN SHOT FORWARD IN THE VESSEL, LEADING TO A VESSEL PERFORATION. THE PHYSICIAN WAS ABLE TO VISUALIZE DYE STAINING. THE PATIENT WAS STABILIZED, AND A BALLOON PUMP AND TEMPORARY PACEMAKER WERE INSERTED. HOWEVER, THE PATIENT'S CONDITION DETERIORATED, THE PATIENT CODED, AND THE PATIENT EXPIRED 15 MINUTES LATER.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LESION WAS APPROXIMATELY 15MM LONG, 99% STENOSED AND THE VESSEL WAS SEVERELY TORTUOUS. THE PLATFORM SPEED OF THE ROTABLATOR SYSTEM WAS 185,000 RPMS. ONE ABLATION RUN WAS PERFORMED FOR 63 SECONDS. THE PHYSICIAN FELT NO RESISTANCE PRIOR TO THE STALL. IN AN EFFORT TO REMOVE THE STUCK BURR, THE PHYSICIAN USED GENTLE TRACTION ON THE GUIDE CATHETER AND ROTALINK SYSTEM. IN THE OPINION OF THE PHYSICIAN, THE BURR BECAME STUCK AND SHOT FORWARD DUE TO THE "EXCESSIVE TORTUOSITY OF TARGET VESSEL". IN THE OPINION OF THE PHYSICIAN, THERE WAS NO MALFUNCTION OF THE DEVICE. THE CAUSE OF DEATH WAS DOCUMENTED AS CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death