BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL WTIH PASV MINI PORT

    MDR report key: 933817 · Received October 29, 2007

    Report

    Report Number
    6000126-2007-00117
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    September 4, 2007
    Report Date
    October 3, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJT
    PMA / PMN Number
    K030083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER AS IT WAS DISPOSED. SINCE NO LOT/BATCH NUMBER WAS PROVIDED, A SHIP HISTORY REPORT WAS GENERATED IN ORDER TO ASCERTAIN THE LAST THREE LOTS SHIPPED TO THE REPORTING CUSTOMER IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. THE THREE LOTS OBTAINED THROUGH THE SHR WERE: 1114768, 1117818 AND 1122767; NO ANOMALIES WERE NOTED. A SIMILAR COMPLAINT TREND REPORT WAS GENERATED AND NO COMPLAINTS WERE REPORTED FOR ANY OF THE THREE LOT NUMBERS ATTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION BY A FEMALE PT THAT, THE CATHETER FOR VAXCEL WITH PASV MINI PORT IMPLANTED FOR THERAPEUTIC PURPOSES IN 2006 HAD "FRACTURED AND VAXCEL PORT [HAD MALFUNCTIONED], KINKED." IN 2007, FOLLOW UP INFORMATION REVEALED THAT THE FRACTURE HAD BEEN NOTICED UNDER FLUOROSCOPY, THAT THE CATHETER DID NOT MIGRATE AND THE PHYSICIAN "DOES NOT BELIEVE IT IS A COMPLETE SEPARATION." THE DEVICE WAS REMOVED A WEEK LATER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PASV PORT. THE PT REPORTED TO BSC, NO COMPLICATIONS RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL WTIH PASV MINI PORT LJT BOSTON SCIENTIFIC M001452150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR