BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2143294 · Received June 29, 2011

    Report

    Report Number
    2134265-2011-02482
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 6, 2011
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED 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 TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE CONTRALATERAL FEMORAL ARTERY. LESIONS BEING TREATED WERE IN THE LEFT SUPERFICIAL FEMORAL ARTERY, POPLITEAL, AND BELOW THE KNEE. THE 100% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS ARTERY. THE STERLING ES OTW 1.5MM X 20MM X 142CM CROSSED THE LESION WITH NO SIGNIFICANT RESISTANCE AND INFLATION WAS PERFORMED. UPON THE FIRST INFLATION, THE BALLOON RUPTURED AT AN UNKNOWN ATM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND 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 H74939134152010 13980461

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: SJM| INFLATION DEVICE: MEDTRONIC| BALLOON CATHETER: BSC AND KANEKA