BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1852540 · Received October 4, 2010

    Report

    Report Number
    2134265-2010-04237
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 22, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE 325 CM FLOPPY ROTAWIRE SHOWS THE COILS MISSING FROM THE SPRING TIP, THE SOLDER WAS DAMAGED. THE CORE WIRE OF SPRING TIP WAS SENT TO SEM (SCANNING ELECTRON MICROSCOPY) FOR FRACTURE ANALYSIS. THE FRACTURE SURFACE WAS CAUSED BY A TORSIONAL TYPE OVERLOAD. NO MATERIAL ANOMALIES WERE OBSERVED. THE TYPE OF DAMAGE THAT OCCURRED INDICATED THAT THIS COULD NOT HAVE BEEN AN ANATOMICAL ISSUE BUT WAS MOST LIKELY DUE TO INTERACTION WITH ANOTHER DEVICE. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS CAUSED BY OTHER DEVICE. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE A GUIDEWIRE SPRING TIP UNRAVELED. THE LESION WAS LOCATED IN A RIGHT CORONARY ARTERY (RCA). UPON REMOVAL OF THE 325CM FLOPPY ROTAWIRE, THE SPRING TIP BECAME "CAUGHT ON SOMETHING" WHICH CAUSED IT TO UNRAVEL OUTSIDE OF THE BODY. THE CASE WAS SUCCESSFULLY COMPLETED PRIOR TO THE WIRE REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. RETUNED PRODUCT ANALYSIS REVEALED A SPRING TIP THAT WAS BROKEN AND UNRAVELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - MIAMI H802228240021

    Patients

    Seq Age Sex Outcome Treatment
    1