BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1443187 · Received April 20, 2009

    Report

    Report Number
    2134265-2009-01741
    Event Type
    Malfunction
    Date Received
    April 20, 2009
    Date of Event
    March 13, 2009
    Report Date
    March 22, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K)#: P860019/S208. THE COMPLAINT DEVICE WAS NOT RETURNED TO BSC FOR ANALYSIS. THE MANUFACTURING RECORDS WERE REVIEWED TO CONFIRM THAT NO ISSUES OR DISCREPANCIES OCCURRED DURING PRODUCTION OF THIS BATCH THAT COULD CONTRIBUTE TO THE REPORTED EVENT. THIS RECORDS REVIEW INDICATED THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. A BROKEN SHAFT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, HANDLING DURING REMOVAL FROM PACKAGING, AND PREPARATION/USE OF THE CATHETER. BECAUSE CURRENT MANUFACTURING CONTROLS INCLUDE INSPECTION OF ALL DEVICES AT NUMBEROUS POINTS WITHIN THE MANUFACTURING PROCESS, IT IS CONSIDERED UNLIKELY THAT THE BROKEN SHAFT OCCURRED PRIOR TO SHIPMENT. THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE HANDLING DAMAGE. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNPACKING FOR AN UNSPECIFIED INTERVENTIONAL PROCEDURE, THE HYPOTUBE "SNAPPED". AN APEX MONORAIL 12MM X 2.00MM BALLOON CATHETER HAD BEEN SELECTED TO TREAT AN UNSPECIFIED LESION. WHILE REMOVING THE DEVICE FROM THE HOOP WITHOUT DIFFICULTY, A "CRACKING SOUND" WAS HEARD AND THE PHYSICIAN "THOUGHT THAT THE HYPOTUBE MAY HAVE SNAPPED". THERE WAS NO VISUAL CONFIRMATION OF DEVICE BREAKAGE AS THE DEVICE WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 2.0X12 MM 11525166

    Patients

    Seq Age Sex Outcome Treatment
    1