BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1990043 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00382
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 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

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT WAS NOTED DURING UNPACKAGING THAT DRIED BLOOD AND CONTRAST WERE PRESENT ON THE OUTER AND INNER SURFACES OF THE DEVICE. THE DEVICE WAS PREPPED ACCORDING TO THE DFU, AND A NEW INFLATION DEVICE FILLED WITH WATER WAS CONNECTED TO THE INFLATION PORT TO INFLATE THE DEVICE. WHEN POSITIVE PRESSURE WAS APPLIED WITH THE INFLATION DEVICE, A STREAM OF WATER EMITTED FROM A HOLE IN THE BALLOON 2 CM FROM THE DISTAL MARKERBAND. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 PERIPHERAL TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED COMMON ILIAC ARTERY. DURING THE FIRST INFLATION WITH A 6.0MM X 60/135 STERLING MONORAIL BALLOON CATHETER, THE BALLOON RUPTURED AT 4 ATMS. THE PROCEDURE WAS COMPLETED WITH A 8.0MM STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED COMMON ILIAC ARTERY. DURING THE FIRST INFLATION WITH A 6.0MM X 60/135 STERLING MONORAIL BALLOON CATHETER, THE BALLOON RUPTURED AT 4 ATMS. THE PROCEDURE WAS COMPLETED WITH A 8.0MM STERLING BALLOON CATHETER. 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 H74939031606010 13811038

    Patients

    Seq Age Sex Outcome Treatment
    1 8.0MM STERLING BALLOON CATHETER| EXPRESS LD STENT CATHETER| STERLING ES 2.0MM BALLOON CATHETER