BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1030702 · Received April 15, 2008

    Report

    Report Number
    2134265-2008-01095
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), A BALLOON RUPTURED OCCURRED. A 4.0X40/80 (4F) F/G STERLING OTW BALLOON WAS USED TO TREAT THE 99% STENOSED, MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE LEFT COMMON FEMORAL ARTERY. ON THE FIRST INFLATION, THE BALLOON WAS INFLATED TO 3 ATMOSPHERES FOR 2 MINS AND ON THE SECOND INFLATION, THE BALLOON WAS INFLATED FOR 1 MIN AT 6 ATMOSPHERES AND ON THE THIRD INFLATION, THE BALLOON WAS INFLATED FOR 15 SECONDS AND RUPTURED AT 10 ATMOSPHERES. THE BALLOON WAS REMOVED IN TACT. THE BALLOON WAS VISIBLE UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT STATUS IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE-WIRE DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION NA 11366137

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: TRANSCENED| INTRODUCER SHEATH: MEDIKIT| INFLATION DEVICE: MEDTRONIC