BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1884911 · Received October 28, 2010

    Report

    Report Number
    2134265-2010-04759
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 (PTA) TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY, IPSOLATERAL APPROACH. THE 100% RE-STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT POSTERIOR TIBIAL ARTERY, BELOW-THE-KNEE (BTK). RESISTANCE WAS ENCOUNTERED UPON ATTEMPTING TO ADVANCE THE 1.5MM X 20MM STERLING ES PTA BALLOON DILATATION CATHETER ACROSS THE LESION AND THE BALLOON RUPTURED AT 10ATMS ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 13554412

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 5FR 25CM MEDIKIT| GUIDE WIRE: EXTREME PV| INFLATION DEVICE: GOODMAN