BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2022536 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00802
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 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: (B)(6). 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. THE 100% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS RIGHT POPLITEAL ARTERY. THE STERLING ES OTW 1.5MM X 20MM X 142CM BALLOON WAS BEING USED FOR PRE-DILATATION. ON THE FIRST INFLATION THE BALLOON RUPTURED AT AN UNKNOWN ATMOSPHERE. THE DEVICE WAS REMOVED INTACT. 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 H74939134152010 14049349

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: MEDIKIT| STENT: J&J| GUIDE WIRE: SJM| INFLATION DEVICE: MEDTRONIC