BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK PLUS

    MDR report key: 1080937 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02049
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 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

    COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED; 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 EVENT AS MFR #: 2134265-2008-02050. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, GUIDE WIRE BREAKAGE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE FLOPPY ROTAWIRE GUIDE WIRE WAS ENGAGED, AND A 1.5 MM ROTALINK WAS ADVANCED TO THE LESION; HOWEVER, IT WAS UNABLE TO CROSS THE LESION. THEREFORE, THE PHYSICIAN EXCHANGED THE 1.5 MM ROTALINK FOR A 1.25 MM ROTALINK; HOWEVER, IT WAS ALSO UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN ATTEMPTED TO DYNAGLIDE OUT OF THE VESSEL, BUT APPROX 1 CM OF THE FLOPPY ROTAWIRE SPRING TIP FRACTURED DURING REMOVAL OF THE 1.25 MM ROTALINK. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SEPARATED TIP, BUT WAS UNSUCCESSFUL. THE SEPARATED GUIDE WIRE TIP DID NOT EMBOLIZE AND REMAINS IN THE DISTAL LAD. THERE IS NO PLAN TO RETRIEVE THE SEPARATED SPRING TIP. IT IS UNK WHETHER OR NOT THE 1.25 ROTALINK BURR CAME INTO CONTACT WITH THE FLOPPY ROTAWIRE SPRING TIP. THE PROCEDURE WAS COMPLETED WITH A 3.00 MM MAVERICK2 BALLOON CATHETER. NO FURTHER PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK PLUS MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC NA 0011524808

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R