BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSTICK II

    MDR report key: 898412 · Received August 17, 2007

    Report

    Report Number
    6000037-2007-00043
    Event Type
    Malfunction
    Date Received
    August 17, 2007
    Date of Event
    July 23, 2007
    Report Date
    July 24, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DYB
    PMA / PMN Number
    K952828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD WAS REVIEWED; ALL RECORDS APPEARED NORMAL. NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES WERE NOTED AT THE TIME OF MANUFACTURE. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 8122899. THE DEVICE WAS RETURNED FOR EVALUATION. THE ACCUSTICK WITH THE TROCAR AND GUIDEWIRE WERE RECEIVED INSIDE THE ORIGINAL POUCH CONTAINING THE PRODUCT LABEL. A VISUAL EVALUATION WAS PERFORMED. THIS EVALUATION FOUND THAT THE OUTER COIL HAD UNRAVELED FROM THE DISTAL TIP OF THE DEVICE, WHILE THE FLOPPY CORE WIRE APPEARED TO BE INTACT. MULTIPLE BENDS WERE IDENTIFIED IN MULTIPLE LOCATIONS ON THE WORKING LENGTH OF THE GUIDEWIRE. THE INNER CORE OF THE WIRE LENGTH WAS FOUND TO BE WITHIN TOLERANCE PER SPECIFICATION. THIS VISUAL EXAMINATION ALSO FOUND THAT THE BALL WELD WAS STILL APPROPRIATELY ATTACHED TO THE OUTER CORE WIRE. THIS VISUAL EVALUATION ALSO FOUND THAT THE DISTAL TIP OF THE CATHETER WAS KINKED. THIS CUSTOMER COMPLAINT CONDITION WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE DAMAGE HAS BEEN DETERMINED TO BE THE RESULT OF USER HANDLING POSSIBLY DURING INTERACTION WITH THE CATHETER. THE JULY 2007 ACCUSTICK PRODUCT FAMILY TRENDING CHART WAS REVIEWED AND THE PRODUCT FAMILY IS AT OR ABOVE THE COMPLAINT ALERT LIMIT AND SHOWS A NEGATIVE TREND. A CORRECTIVE ACTION REQUEST HAS BEEN SUBMITTED FOR THIS ISSUE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT CLINICIANS WERE PERFORMING THE THERAPEUTIC DRAINAGE PROCEDURE ON A PATIENT (AGE AND GENDER UNKNOWN), USING THE ACCUSTICK II. DURING THE PROCEDURE THE INTRODUCER WIRE SHEARED OFF INSIDE PATIENT. THE CLINICIANS SUCCESSFULLY REMOVED A PORTION OF THE SHEARED OFF MATERIAL BY HAND. A PORTION OF THE MATERIAL REMAINED IN THE PATIENT. THE CLINICIANS THEN OBTAINED ANOTHER DEVICE AND SUCCESSFULLY COMPLETED THE PATIENT PROCEDURE. THE COMPLAINANT INDICATED THAT THEY FEEL THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS REPORTED TO BE "FINE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSTICK II DYB BOSTON SCIENTIFIC NA 8122899

    Patients

    Seq Age Sex Outcome Treatment
    1 YR