BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR CATHETER

    MDR report key: 1221233 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04234
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AT THE USER FACILITY AND 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFG# 2134265-2008-04233. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMENIAL CORONARY INTERVENTION PROCEDURE, WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED AND A GUIDE WIRE FRACTURE OCCURRED. THE ARTERY AND LESION LOCATION AND CHARACTERISTICS ARE UNKNOWN. THE ROTABLATOR (RTW) FLOPPY GUIDEWIRE WAS USED WITH A ROTALINK BURR AND ADVANCED TO THE LESION. AFTER THE FIRST ABLATION WITH THE BURR, IT BECAME STUCK IN THE ARTERY. FORCE WAS APPLIED TO THE BURR AND ATTEMPTS TO WITHDRAW WERE UNSUCCESSFUL. THE PHYSICIAN THEN ACTIVATED THE BURR AT 140,000 RPM'S AND THE BURR WAS SUCCESSFULLY REMOVED, HOWEVER, THE DISTAL TIP OF THE GUIDE WIRE BROKE. THE GUIDE WIRE FRAGMENT REMAINS IN THE PATIENT. IT WAS REPORTED THAT NO ACTION WAS TAKEN TO RESOLVE THE EVENT AT THAT TIME, NOR IS IT KNOWN IF THE EVENT HAS BEEN RESOLVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. POST PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "STABLE". NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other