BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAWIRE? AND WIRECLIP? TORQUER

    MDR report key: 4143379 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-05902
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.; THE VISUAL AND TACTILE INSPECTION WAS PERFORMED . THE DEVICE WAS RETURNED IN TWO SECTIONS. PART#1 (PROXIMAL SECTION) AND PART#2 (DISTAL SECTION). THE DISTAL SECTION WAS FOUND KINKED AT 127.2CM APPROXIMATELY FROM THE DISTAL END. THE RETURNED DEVICE PRESENTS EVIDENCE OF WEAR REDUCTION AS MODE OF WIRE FAILURE. BASED ON ALL GATHERED INFORMATION, NO FURTHER ACTIONS ARE CONSIDERED NECESSARY. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME MDR ID AS 2134265-2014-05903. IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A 330CM ROTAWIRE¿ AND WIRECLIP¿ TORQUER AND A 1.50MM ROTALINK¿ BURR WERE SELECTED TO TREAT THE LESION. UPON PLATFORMING, IT WAS NOTED THAT THE BURR CUT THE WIRE. THE PHYSICIAN PULLED THE WIRE COMPLETELY OUT OF THE BODY AND ANOTHER WIRE WAS USED TO RUN THE BURR OVER THE NEW WIRE. HOWEVER, IT WOULD NOT TRACK OVER THE WIRE, THE PHYSICIAN HAD TO USE A NEW BURR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME MDR ID AS 2134265-2014-05903. IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A 330CM ROTAWIRE¿ AND WIRECLIP¿ TORQUER AND A 1.50MM ROTALINK¿ BURR WERE SELECTED TO TREAT THE LESION. UPON PLATFORMING, IT WAS NOTED THAT THE BURR CUT THE WIRE. THE PHYSICIAN PULLED THE WIRE COMPLETELY OUT OF THE BODY AND ANOTHER WIRE WAS USED TO RUN THE BURR OVER THE NEW WIRE. HOWEVER, IT WOULD NOT TRACK OVER THE WIRE, THE PHYSICIAN HAD TO USE A NEW BURR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623470 ROTAWIRE? AND WIRECLIP? TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H802228240022 0017001746

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR ROTALINK BURR 1.50MM -CATHETER