BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE WIRE

    MDR report key: 1172135 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02712
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED, THEREFORE PRODUCT ANALYSIS WAS NOT POSSIBLE. THE MANUFACTURING RECORDS FOR THIS BATCH HAVE BEEN REVIEWED, AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. THE MOST PROBABLE ROOT CAUSE WILL BE CONSIDERED OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS SEVERELY CALCIFIED AND LOCATED IN THE SHUNT OF THE LEFT ANTEBRACHIAL. IT WAS INSERTED FROM THE VEIN SIDE BY RETROGRADE APPROACH. THE VEIN AROUND THE ANASTOMOSIS SITE WAS DILATED WITH THE F/G STERLING OTW 6.0 X 40/80 (4F). ON THE FIRST INFLATION THE BALLOON WAS INFLATED TO 10 ATMOSPHERES BUT THE LESION WAS NOT DILATED ENOUGH. ON THE SECOND INFLATION THE BALLOON WAS INFLATED TO 22 ATMOSPHERES AND RUPTURED. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS WITH ANOTHER OF THE SAME DEVICE. THE PATIENT STATUS IS "NO PROBLEM" WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE WIRE DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION NA 11537590

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: MOSQUITO 5FR| GW: AQUA