BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2032841 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-00947
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL AND TACTILE INSPECTION OF THE PROXIMAL HUB AND SHAFT PRESENTED NO DAMAGE OR IRREGULARITIES. MICROSCOPIC EXAMINATION OF THE DISTAL END OF THE CATHETER REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL. THE TEAR WAS < 1 MM FROM THE DISTAL EDGE OF THE DISTAL MARKERBAND EXTENDING 15 MM PROXIMALLY. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL AT THE EDGES OF THE TEAR PRESENTED NO INDICATION OF AN INITIATION POINT OR ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE FORMATION OF THE TEAR. 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.THE PROCEDURE TREATED THE 90% RESTENOSED, NON BSC PREVIOUSLY PLACED STENT LOCATED IN THE MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTEY. A 4.0X60MM STERLING BALLOON CATHETER WAS ADVANCED TO PRE-DILATE THE TARGET LESION. THE BALLOON RUPTURED ON THE 1ST INFLATION AT 6 ATM'S. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031406010 13719575

    Patients

    Seq Age Sex Outcome Treatment
    1 6FR SHEATHLESS PV| SMART STENT| CRUISE GUIDEWIRE