BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASV PICC

    MDR report key: 980136 · Received September 28, 2007

    Report

    Report Number
    6000126-2007-00111
    Event Type
    Malfunction
    Date Received
    September 28, 2007
    Date of Event
    July 11, 2007
    Report Date
    August 14, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    LJS
    PMA / PMN Number
    K981368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT A COMPLETE EVAL HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT IS UNDETERMINED. INITIAL OBSERVATIONS REVEALED THAT THERE ARE 2 HOLES DISTAL TO THE SUTURE WING (SEE FIG 1, BELOW) . THE ACTUAL FEQUENCY OF THE REPORTED "CATHETER LEAK DISTAL TO THE SUTURE WING "FAILURE MODE IS WITHIN THE EXPECTED OCCURRENCE RATE AS CITED IN THE VAXCEL PASV PICC PRODUCT RISK ANALYSIS DOCUMENTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON 08/02/2007 THAT A VAXCEL PASV PICC WAS USED IN A PICC LINE IMPLANT PROCEDURE IN A FEMALE PT IN 2007. ACCORDING TO USER, THE "PICC LINE (WAS) PLACED, (AND) ATTEMPTS TO FLUSH AND GET BLOOD RETURN [WERE] UNSUCCESSFUL. THE BURGANDY LINE WOULD FLUSH, BUT COULD NOT GET BLOOD RETURN. THE GRAY LINE, WHEN DRAWING BACK - HAD AIR RETURNED. WHEN FLUSHING, THE FLUSH DRAINED OUT OF THE CATHETER HUB. [THE] [P]HYSICIAN REPLACED [THE] CATHETER." FOLLOW UP INFO REVEALED THAT THE SECOND CATHETER WAS ANOTHER OF THE SAME VAXCEL PASV PICC. ACCORDING TO THE USER MEDWATCH, THERE WAS "NO ADVERSE OUTCOME" FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASV PICC FOZ LJS BOSTON SCIENTIFIC CORP M001454780 1198426

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR