BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2101111 · Received May 24, 2011

    Report

    Report Number
    2134265-2011-01882
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    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

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 AND/OR 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% IN-STENT RESTENOSED LESION IN AN UNKNOWN STENT, WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT RADIAL VEIN. SEVERE RESISTANCE WAS FELT CROSSING THE LESION WITH A NON BCS 0.018 INCH GUIDE WIRE. THE PHYSICIAN FELT MILD RESISTANCE WHEN CROSSING THE LESION WITH THE 4.00 X 60 X135 STERLING BALLOON FOR PRE-DILATION. ON THE FIRST INFLATION, THE BALLOON WAS INFLATED TO 8 ATMS FOR 60 SECONDS. ON THE SECOND INFLATION, THE BALLOON WAS INFLATED TO 10ATMS FOR 60 SECONDS. UPON THE THIRD INFLATION TO 12ATMS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A NON BSC 4.0 X 100MM BALLOON. 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 BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031406010 13911340

    Patients

    Seq Age Sex Outcome Treatment
    1 0.018 TERUMO GUIDE WIRE| EVEREST INFLATION DEVICE| 4FR TERUMO INTRODUCER SHEATH