BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL CHEST PORTS

    MDR report key: 939607 · Received November 8, 2007

    Report

    Report Number
    6000126-2007-00122
    Event Type
    Malfunction
    Date Received
    November 8, 2007
    Date of Event
    October 18, 2007
    Report Date
    October 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJT
    PMA / PMN Number
    K982888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE AT THIS TIME TO DETERMINE IF THE DEVICE MET SPECIFICATION, AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. THE DEVICE HISTORY RECORDS FOR THIS LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS FOR LOT NUMBER 1210595. NO ADVERSE TRENDS WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED, THAT THE CLINICIANS WERE PERFORMING A THERAPEUTIC IMPLANT OF A VAXCEL CHEST PORT IN A FEMALE PATIENT. DURING THE PROCEDURE, THE CLINICIAN INSERTED THE PEEL AWAY PORTION, PULLED THE DILATOR AND WIRE OUT, AND THEN PUT THE PORT CATHETER AND TUBING INTO THE PEEL AWAY PORTION OF THE DEVICE. WHEN THE NURSE THEN TRIED TO PEEL THE SHEATH, THE TAB/WING BROKE OFF AND DID NOT STAY ATTACHED TO THE REST OF THE SHEATH. THE COMPLAINANT REPORTED THAT NO PORTION OF THE SHEATH REMAINED IN THE PATIENT. THE NURSE PRACTITIONER THEN OBTAINED ANOTHER DEVICE AND SUCCESSFULLY COMPLETED THE PATIENT PROCEDURE. THE NURSE PRACTITIONER DID REPORT THAT THE PATIENT EXPERIENCED SLIGHT BLEEDING POST PROCEDURE, BUT THAT IT WAS NOT RELATED TO THE REPORTED PROBLEM AND THAT THERE WAS NO ADVERSE AFFECT ON THE PATIENT AS A RESULT OF THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL CHEST PORTS LJT BOSTON SCIENTIFIC M001453030 1210595

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR