BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING MONORAIL

    MDR report key: 1033535 · Received April 24, 2008

    Report

    Report Number
    2134265-2008-01185
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K053118
    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 FOR A PT WITH PERIPHERAL ARTERY DISEASE, A 6.0X60/135 (4F) F/G STERLING MONORAIL BALLOON RUPTURED. THE 100% STENOSED LESION WAS MODERATELY TORTUOUS AND NO CALCIFICATION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A NON BSC GUIDEWIRE AND A 5.0*100*135 STERLING WERE ACCESSED TO THE LESION AND CROSSED COAXIALLY. THEN A NON BSC STENT WAS IMPLANTED IN THE LESION. THE PHYSICIAN THEN USED A 6.0X60/135 (4F) F/G STERLING MONORAIL FOR POST DILATATION, HOWEVER, ON THE FIRST INFLATION AT THE DISTAL SIDE OF THE STENT, A PINHOLE RUPTURE WAS OBSERVED WHEN BALLOON WAS BEING INFLATED TO 6 ATMOSPHERES FOR A FEW SECONDS. THE BALLOON WAS REMOVED INTACT. THE BALLOON WAS VISIBLE UNDER FLUOROSCOPY. PROCEDURE WAS COMPLETED WITH A STERLING 6.0X100/135 BALLOON. THE PT STATUS IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION NA 11066464

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: SMART (J&J)| INTRODUCER SHEATH: MEDIKIT PARENT 6F| GUIDEWIRE: THRUWAY 018