BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTAWIRE¿ AND WIRECLIP¿ TORQUER

    MDR report key: 5152740 · Received October 15, 2015

    Report

    Report Number
    2134265-2015-06977
    Event Type
    Death
    Date Received
    October 15, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 22, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: ((B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2015-06976 AND 2134265-2015-06978. IT WAS REPORTED THAT THE PATIENT DIED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 35X3.2MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILD TO MODERATELY CALCIFIED OSTIAL TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 1.50MM ROTALINK PLUS AND 330CM ROTAWIRE WERE USED FOR TREATMENT. THE SPEED WAS SET AT 160,000RPMS AND ABLATIONS WERE DONE THREE TIMES AT 40 SECONDS DURATION. THERE WERE NO RESTRICTIONS ENCOUNTERED AND THE WIRE HAD NO FRACTURE OR BENDING ISSUES. POST-DILATATION WAS THEN PERFORMED USING A 2.75 NC BALLOON CATHETER. HOWEVER, IMMEDIATELY AFTER POST-DILATATION, THE PATIENT EXPERIENCED TACHYCARDIA RESULTING IN PULMONARY EDEMA. A 3.00X38MM PROMUS ELEMENT LONG DRUG-ELUTING STENT WAS THEN ADVANCED AND IMPLANTED. THE PATIENT WAS ALSO TREATED WITH INTRA-AORTIC BALLOON PUMP (IABP) AND CARDIAC MASSAGING; HOWEVER, PATIENT'S CONDITION DID NOT IMPROVE. SUBSEQUENTLY, THE PATIENT WENT INTO CARDIAC ARREST AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684127 ROTAWIRE¿ AND WIRECLIP¿ TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H802228240022 17642470

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death