BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1954951 · Received January 10, 2011

    Report

    Report Number
    2134265-2010-05957
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: 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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE BURR BECAME STUCK IN THE LESION. THE 99% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ADVANCED THE 1.25MM ROTABLATOR ROTALINK PLUS BURR AND ABLATION WAS PERFORMED SEVERAL TIMES. DURING AN UNSPECIFIED ABLATION, THE BURR WAS ADVANCED TO THE DISTAL PORTION OF THE LESION, BECAME STUCK AND THE SYSTEM STALLED. THE ROTABLATOR ROTALINK PLUS SYSTEM AND THE GUIDE WIRE WERE MANUALLY PULLED FROM THE PATIENT AS A UNIT. OUTSIDE THE PATIENT THE PHYSICIAN NOTED THE COIL SHAFT ON THE BURR WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 13724229

    Patients

    Seq Age Sex Outcome Treatment
    1 7FR MACH1 GUIDE CATHETER