BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAWIRE GUIDEWIRE

    MDR report key: 1024349 · Received April 3, 2008

    Report

    Report Number
    2134265-2008-00968
    Event Type
    Injury
    Date Received
    April 3, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A GUIDE WIRE TIP SEPARATION OCCURRED. THE 99% STENOSED AND CALCIFIED LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). ANOTHER MANUFACTURER'S GUIDE WIRE WAS PLACED AND AN UNSPECIFIED ASPIRATION CATHETER WAS ADVANCED TO EVACUATE THROMBUS. AN UNSPECIFIED 2.0MM BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION OF THE LESION, HOWEVER, THE NUMBER OF INFLATIONS AND TO WHAT ATMS THE BALLOON REACHED ON EACH INFLATION IS UNKNOWN. FOLLOWING PRE-DILATATION, THE PHYSICIAN NOTED THAT THE LESION WAS NOT ADEQUATELY DILATED. THE GUIDE WIRE WAS EXCHANGED FOR A ROTAWIRE EXTRA SUPPORT GUIDE WIRE AND A 1.75MM BURR WAS ADVANCED TO ABLATE THE LESION. THE NUMBER OF RUNS MADE WITH THE BURR IS UNKNOWN. UPON ATTEMPTING TO EXCHANGE THE ROTAWIRE FOR ANOTHER MANUFACTURER'S GUIDE WIRE, THE PHYSICIAN NOTED THAT THE TIP OF THE ROTAWIRE HAD DETACHED AND REMAINED INSIDE THE PATIENT. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED TO RETRIEVE THE DETACHED PORTION AND THE SEGMENT WAS SUCCESSFULLY REMOVED. AN UNSPECIFIED 3.25MM BALLOON CATHETER WAS ADVANCED TO PRE-DILATE THE LESION FURTHER AND AN UNSPECIFIED TAXUS STENT WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTAWIRE GUIDEWIRE MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC NA 11397901

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention NEO'S FIELDER GUIDE WIRE