BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI-PLAST XT PTA BALLOON DILATATION CATHETER

    MDR report key: 2223330 · Received August 15, 2011

    Report

    Report Number
    2020394-2011-00192
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K941706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ANGIOPLASTY WAS PERFORMED, THE PTA BALLOON COULD NOT BE WITHDRAWN THROUGH THE 6F INTRODUCER SHEATH. BOTH THE PTA BALLOON DILATATION CATHETER AND THE INTRODUCER SHEATH WERE REMOVED SIMULTANEOUSLY. ANOTHER SHEATH WAS PLACED AND THE PROCEDURE WAS COMPLETED. NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-PLAST XT PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. GFTJ0628

    Patients

    Seq Age Sex Outcome Treatment
    1