BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 3000375 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01365
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. USING A LEFT FEMORAL APPROACH, THE 90% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED, NON-TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. USING A NON-BSC GUIDEWIRE, THE 6.0 X 100/135 STERLING BALLOON CATHETER WAS ADVANCED TO THE LESION WHEN THE BALLOON RUPTURED AT 14ATMS UPON FIRST INFLATION. THE RUPTURED BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103802 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032601010 15744267

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR INTRODUCER SHEATH: TERUMO 6X45 SHEATH| GUDEWIRE: AV18