BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2062927 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01190
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AN INITIAL EXAMINATION OF THE COMPLAINT UNIT WAS NOT CARRIED OUT AS THE PRODUCT WAS NOT RETURNED TO SITE FOR INVESTIGATION. THE DEVICE WAS DISPOSED OF AT THE USER FACILITY. 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#: 2134265-2011-01191. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A DISSECTION OCCURRED. THE 90% STENOSED, 25-28MM LONG X 3.0MM LESION WAS LOCATED IN THE MODERATELY TO SEVERELY CALCIFIED AND MILDLY TORTUOUS MID PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL. THE 1.5MM ROTALINK BURR WAS PLATFORMED AT 160,000 RPMS. THE PHYSICIAN THEN ADVANCED THE BURR TO THE LESION ON THE FLOPPY ROTAWIRE GUIDE WIRE, INITIALLY NOTING RESISTANCE WHICH HE ADVANCED THROUGH. A COUPLE OF ABLATION RUNS WERE PERFORMED FOR APPROXIMATELY 30 SECONDS AND THE BURR WENT THROUGH THE LESION. THE BURR THEN BECAME STUCK AND STALLED. THE PHYSICIAN ATTEMPTED TO BURP THE FOOT PEDAL IN AN ATTEMPT TO REMOVE THE BURR, HOWEVER THE NON-BSC GUIDE CATHETER BECAME SUCKED IN CAUSING A DISSECTION IN THE UNPROTECTED LEFT MAIN ARTERY. THE PATIENT HAD NO ADVERSE SYMPTOMS DUE TO THE DISSECTION, AND TWO PROMUS STENTS WERE PLACED TO TREAT THE DISSECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030 13934383

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention MEDTRONIC 7FR LAUNCHER GUIDE CATHETER| FLOPPY ROTAWIRE GUIDE WIRE 330CM