BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1832458 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04073
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 26, 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 COMPLAINT DEVICE WAS NOT RETURNED TO BSC 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 UNSPECIFIED TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT EXTERNAL ILIAC ARTERY (EIA). FOLLOWING IMPLANT OF ANOTHER MANUFACTURER'S STENT, THE 8.0 X 40/135 STERLING BALLOON CATHETER WAS INTRODUCED AND RUPTURED ON THE THIRD INFLATION AT 12 ATMS. THE FIRST TWO INFLATIONS WERE TO 12 ATMS. THE PROCEDURE OUTCOME IS UNKNOWN. 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 H74939031804010 13411169

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE, TREASURE| STENT, SMART| INTRODUCER SHEATH, 6F PARENT