BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2180290 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-02917
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT EVALUATED BY MFG.: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIALS, 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 A CALCIFIED, AND MODERATELY TORTUOUS VEIN SHUNT. THE F/G STERLING OTW 6.0 X 20/40 (4F) BALLOON CATHETER WAS INFLATED ONCE TO 8ATM AND RUPTURED. NO RESISTANCE WAS FELT DURING USE. THIS PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032602040 14272691

    Patients

    Seq Age Sex Outcome Treatment
    1 Other