BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOOTPRINT MEDICAL PICC 1.4FR

    MDR report key: 5780182 · Received July 8, 2016

    Report

    Report Number
    3007697249-2016-06001
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    May 12, 2016
    Report Date
    July 7, 2016
    Manufacturer
    FOOTPRINT MEDICAL, INC.
    Product Code
    LJS
    PMA / PMN Number
    K130507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CATHETER IS REPORTED TO HAVE BEEN IN THE PATIENT AND PRESUMABLY PERFORMING AS INTENDED FOR OVER 60 DAYS OF THERAPY. IT IS PROBABLE THAT THE CATHETER BECAME ADHERED TO THE VESSEL WALL DURING THE COURSE OF THERAPY DUE TO FIBRIN SHEATH GROWTH. THE CATHETER WAS NOT MADE AVAILABLE FOR INVESTIGATION BY THE FACILITY NOR DID THE FACILITY CONTACT THE MANUFACTURER AT THE TIME OF THE INCIDENT. FURTHERMORE, THE FACILITY IS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION OTHER THAN WHAT IS REPORTED TO THE FDA REGARDING THIS INCIDENT. THE GROWTH OF A FIBRIN SHEATH ON AN INTRAVASCULAR CATHETER IS A WELL-DOCUMENTED COMPLICATION IN THE LITERATURE AND IS INCLUDED IN THE LABELING OF THIS DEVICE AS A KNOWN COMPLICATION. ALTHOUGH INFREQUENT, ADHESION OF THE CATHETER TO THE VESSEL IS ALSO A KNOWN COMPLICATION AND DEPENDS ON UNPREDICTABLE FACTORS RELATED, IN PART, TO THE PATIENT'S BIOLOGICAL RESPONSE TO THE CATHETER. WHEN OTHER MEANS ARE EXHAUSTED, SURGICAL REMOVAL OF A STUCK LINE IS AN UNFORTUNATE BUT COMMON PRACTICE IN THIS SCENARIO. THIS IS THE FIRST INCIDENCE OF THIS NATURE REPORTED FOR THIS PRODUCT LINE. FOOTPRINT MEDICAL INC. POLYURETHANE PIC CATHETERS ARE MADE FROM BIOCOMPATIBLE MATERIALS THAT HAVE YEARS OF SERVICE IN THE INTRAVASCULAR CATHETER AND IMPLANTABLES MARKET. THERE IS NO REASON TO SUSPECT THIS INCIDENT HAS BEEN CAUSED BY THE MATERIALS OR MANUFACTURE OF THE DEVICE.

    Description of Event or Problem · 1

    USER WAS UNABLE TO DISCONTINUE/REMOVE THE 1.4 FR POLYURETHANE PIC CATHETER AFTER KNOWN MEASURES TO FACILITATE CATHETER REMOVAL WERE APPLIED. THE PICC WAS REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433096 FOOTPRINT MEDICAL PICC 1.4FR PICC; PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER LJS FOOTPRINT MEDICAL, INC. P1PIC1.4-C 15584

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention