BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1781853 · Received August 3, 2010

    Report

    Report Number
    2134265-2010-03379
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE 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 PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT POPLITEAL ARTERY. THE PHYSICIAN ADVANCED THE 3 X 40 STERLING ES PTA BALLOON DILATATION CATHETER ACROSS THE LESION. THE BALLOON WAS INFLATED ONE TIME TO 5 ATMS AND RUPTURED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 H74939135304010 12872986

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: B BROWN| GUIDEWIRE: SJM| INTRODUCER SHEATH: MEDIKIT