BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1830114 · Received September 10, 2010

    Report

    Report Number
    2134265-2010-03961
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED SO A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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 90% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. THE STERLING MR BALLOON WAS INFLATED 4 TIMES TO 12 TO 14 ATMS. ON THE FIFTH INFLATION, THE BALLOON RUPTURED AT 12 ATMS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031606010 13162337

    Patients

    Seq Age Sex Outcome Treatment
    1 V18 GUIDE WIRE| TERUMO 6FR INTRODUCER SHEATH