BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVXCEL PASV PICC

    MDR report key: 917137 · Received September 21, 2007

    Report

    Report Number
    6000126-2007-00107
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 18, 2007
    Report Date
    August 29, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FOZ
    PMA / PMN Number
    K981368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EVALUATION HAS NOT BEEN PERFORMED. WE ARE UNABLE AT THIS TIME TO DETERMINE IF THE DEVICE MET SPECIFICATION. UPON RECEIPT OF THE COMPLAINT DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THERE WERE NO PREVIOUS COMPLAINTS REPORTED FOR LOT NUMBER 1203549. THE COMPLAINT REPORT FOR THE MONTH OF JULY 2007 WAS REVIEWED FOR THE VAXCEL PASV PICC DUAL LUMEN PRODUCT FAMILY. NO ADVERSE TRENDS WERE DETECTED FOR "FRACTURE DISTAL TO THE SUTURE WING", "HOLE IN CATHETER", "LEAKAGE", OR "OCCLUDED" FOR THE LAST 15 MONTHS. 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 THERAPEUTIC IMPLANT OF A VAXCEL PASV PICC WAS PERFORMED ON A MALE PATIENT IN 2007. ON THE NEXT DAY, THE NURSE NOTED THAT THERE WAS A CLOT IN ONE OF THE LUMENS OF THE DEVICE. THE NURSE ATTEMPTED TO DE-CLOT THE LUMEN WITH TPA. THIS ATTEMPT WAS UNSUCCESSFUL AND THE DECISION WAS MADE TO REMOVE THE LINE AND REPLACE IT WITH ANOTHER 5FR DUAL LUMEN PICC. UPON REMOVAL, A HOLE WAS FOUND IN THE NON-CLOTTED LUMEN. THE HOLE WAS REPORTED TO BE LOCATED AT THE VERY DISTAL END OF THE CATHETER, WHICH IS THE PORTION OF THE CATHETER LOCATED IN THE SUPERIOR VENA CAVA OF THE PATIENT. THE COMPLAINANT REPORTED THERE WERE NO ADVERSE AFFECTS ON THE PATIENT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVXCEL PASV PICC FOZ BOSTON SCIENTIFIC NA 1203549

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR