BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3221390 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04764
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    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

    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RECEIVED INSIDE A CARRIER TUBE (HOOP) WITHIN A STERLING SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. MAGNIFIED INSPECTION REVEALED NO DAMAGE TO THE CATHETER. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE (RBP) WITH AN INFLATION DEVICE FILLED WITH WATER. THE DEVICE MAINTAINED RBP FOR FIVE (5) MINUTES WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. FUNCTIONAL TESTING REVEALED NO EVIDENCE OF THE ALLEGED BALLOON BURST. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED FOREARM ARTERY. A 6.0MM X 40MM X 80CM STERLING¿ BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. UPON THIRD INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED FOREARM ARTERY. A 6.0MM X 40MM X 80CM STERLING BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. UPON THIRD INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320661 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032604080 13837045

    Patients

    Seq Age Sex Outcome Treatment
    1