BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2072748 · Received April 29, 2011

    Report

    Report Number
    2134265-2011-01413
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 4, 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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. A 2.0X40MM STERLING BALLOON CATHETER WAS ADVANCED TO PRE-DILATE THE TARGET LESION. UPON THE FIRST INFLATION AT 6 ATM'S THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS 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 H74939134204010 13752629

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 0.014 CRUISE GUIDE WIRE 175CM| GOODTECH INFLATION DEVICE| 5R MEDIKIT 55CM INTRODUCER