BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER

    MDR report key: 1203350 · Received October 15, 2008

    Report

    Report Number
    2134265-2008-03018
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K953602
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE BALLOON CATHETER WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE BALLOON CATHETER COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, DEFLATION AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. UPON ATTEMPTING TO WITHDRAW THE SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER, THE BALLOON DID NOT DEFLATE PROPERLY FOR REMOVAL THROUGH AN UNSPECIFIED 5FR SHEATH. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 0011949715

    Patients

    Seq Age Sex Outcome Treatment
    1