BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1823827 · Received September 2, 2010

    Report

    Report Number
    2134265-2010-03806
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 9, 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

    (B)(4). 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. THE PHYSICIAN WAS PRE-DILATING A 99% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED, 3MM IN DIAMETER, ANTERIOR TIBIAL ARTERY WITH THIS 3MM X 40MM X 145CM STERLING ES BALLOON CATHETER. THE BALLOON RUPTURED ON THE FIRST INFLATION AT 6ATMS AFTER BEING INFLATED FOR 5 TO 10 SECONDS. THE DEVICE WAS REMOVED FROM THE PATIENT 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 H74939134304010 12272449

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 4F RADIFOCUS| INFLATION DEVICE: ENCORE| GUIDE WIRE: CRUISE