BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAWIRE? AND WIRECLIP? TORQUER

    MDR report key: 3953025 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04275
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: DEVICE HAS BEEN RETURNED FOR ANALYSIS. VISUAL AND TACTILE INSPECTION WAS PERFORMED AND THE DEVICE WAS RETURNED STUCK INSIDE THE CATHETER. THE DEVICE WAS REMOVED FROM THE CATHETER AND FOUND A KINKED ALONG THE BODY. THE SPRING TIP IS PARTIALLY DETACHED AND DEFORMED. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. 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:2134265-2014-04276. IT WAS REPORTED THAT THE TIP OF THE ROTAWIRE WAS BROKEN. THE 90% STENOSED TARGET LESION WAS LOCATED ON A MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 330CM ROTAWIRE AND A 1.25MM ROTALINK¿ BURR WERE USED FOR TREATMENT. DURING PROCEDURE, THE FOOT PEDAL WAS PERFORMING IRREGULARLY, SOMETIMES IT WOULD ENGAGE AND SOMETIMES IT WOULD NOT. RESISTANCE WAS ENCOUNTERED WHILE THE BURR WAS ADVANCED AND THE RPM KEPT DROPPING. IT WAS ALSO OBSERVED THAT WHEN THE FOOT PEDAL WAS STEPPED EVERYTHING WOULD DROP. THE ISSUE WAS REPORTED TO THE BIOMED TO CHECK THE DEVICE. THE TANK WAS NOTED TO BE FULL. AFTER THE PROCEDURE, THE BURR WAS REMOVED FROM THE PATIENT WITH NO RESISTANCE. IT WAS THEN NOTED THAT THE TIP OF THE WIRE BROKE OFF AND ADVANCED DOWNSTREAM DIAGONALLY AND WAS NON RETRIEVABLE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430385 ROTAWIRE? AND WIRECLIP? TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H802228240022 0016881383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other