BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2021557 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00758
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 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)(4). DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF AN STERLING ES BALLOON CATHETER. VISUAL INSPECTION NOTED DURING UNPACKAGING THAT DRIED BLOOD AND CONTRAST WERE PRESENT IN THE GUIDE WIRE LUMEN AND BALLOON. THE DEVICE WAS PREPPED ACCORDING TO THE DFU. WHEN POSITIVE PRESSURE WAS APPLIED WITH THE INFLATION DEVICE, A STREAM OF WATER EMITTED FROM A HOLE IN THE BALLOON 1 MM FROM THE DISTAL EDGE OF THE MARKERBAND. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL AND THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 TRANSLUMIAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED BELOW THE LEFT KNEE. A 2MM X 40MM X 145CM STERLING ES MONORAIL BALLOON CATHETER WAS INFLATED FIVE TIMES TO 6 ATMS AND DURING THE 5TH INFLATION A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED INTACT AND 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 H74939135204010 13385280

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE, EVEREST| GUIDE WIRE, RUNTHROUGH PERIPHERAL| INTRODUCER SHEATH,4FR TERUMO