BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAWIRE? AND WIRECLIP? TORQUER

    MDR report key: 3842859 · Received June 2, 2014

    Report

    Report Number
    2134265-2014-03216
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS AND OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED IN A GENERIC PLASTIC BAG. THE VISUAL AND TACTILE INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS A WHITE POWDER ALONG THE BODY. 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 ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MILD FLAKING/PEELING OF THE WIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 330CM ROTAWIRE WAS SELECTED. WHILE INTRODUCING A 1.25MM ROTALINK BURR, WHILE STILL EXTERNAL TO THE PATIENT, IT WAS NOTED THAT THE BURR WAS NOT ADVANCING SMOOTHLY ON THE WIRE. A MILD FLAKING/PEELING OF THE ROTAWIRE WAS OBSERVED. THE ROTAWIRE WAS EXCHANGED FOR ANOTHER WIRE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MILD FLAKING/PEELING OF THE WIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 330CM ROTAWIRE¿ WAS SELECTED. WHILE INTRODUCING A 1.25MM ROTALINK BURR, WHILE STILL EXTERNAL TO THE PATIENT, IT WAS NOTED THAT THE BURR WAS NOT ADVANCING SMOOTHLY ON THE WIRE. A MILD FLAKING/PEELING OF THE ROTAWIRE WAS OBSERVED. THE ROTAWIRE WAS EXCHANGED FOR ANOTHER WIRE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320761 ROTAWIRE? AND WIRECLIP? TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H802228240022 16525506

    Patients

    Seq Age Sex Outcome Treatment
    1