BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAXCEL PASV PICC

    MDR report key: 857893 · Received May 31, 2007

    Report

    Report Number
    6000126-2007-00062
    Event Type
    Injury
    Date Received
    May 31, 2007
    Date of Event
    May 7, 2007
    Report Date
    May 10, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJS
    PMA / PMN Number
    K021704
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN REC'D BY THIS MFR, BUT AN EVAL HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. THE APRIL 2007, 15-MONTHS PICCS VALVED COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURES MODES WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A VAXCEL PASV PICC HAD BEEN THERAPEUTICALLY IMPLANTED IN AN FEMALE PT IN 2007. 46 DAYS SUBSEQUENT TO THE DEVICE IMPLANT, PT TREATMENT HAD CONCLUDED. THE CLINICIANS THEN EXPLANTED THE DEVICE. DURING THE PLANNED EXPLANT ONLY 5 - 7CM OF THE CATHETER COULD BE REMOVED FROM THE PT AS IT BROKE INSIDE THE PT. THE CLINICIANS HAD TO "FISH OUT" THE REST OF THE CATHETER. IT IS BELIEVED THAT THE CLINICIANS REMOVED THE DETACHED SECTION OF THE CATHETER WITH THE AID OF A SNARE. THE CLINICIANS WERE SUCCESSFUL IN REMOVING THE ENTIRE DEVICE FROM THE PT. THE COMPLAINANT INDICATED THAT THERE WERE NO ADVERSE AFFECTS TO THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PASV PICC LJS BOSTON SCIENTIFIC NA 1170912

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention