BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEPICC

    MDR report key: 7878827 · Received September 14, 2018

    Report

    Report Number
    2032582-2018-00003
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    July 17, 2018
    Report Date
    September 14, 2018
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    LJS
    UDI-DI
    00813623013728
    PMA / PMN Number
    K083873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW PERFORMED AND NO CONTRIBUTING FACTORS WERE FOUND FOR THE ISSUE. THE GUIDEWIRE IS A COMPONENT OF THE END PRODUCT AND IS NOT MANUFACTURED BY PFM MEDICAL, INC. THE PRODUCT AND COMPONENT HAD NO ASSOCIATED NON-CONFORMANCES OR SIMILAR ISSUES REPORTED. NO FURTHER INVESTIGATION POSSIBLE WITHOUT THE DEVICE RETURNED. REPORTER CHECK IN WITH THE VASCULAR SURGEON MULTIPLE TIMES TO SEE HOW THE PATIENT WAS DOING.

    Description of Event or Problem · 1

    ISSUE WITH A GUIDE WIRE IN WHICH RESULTED IN THE PATIENT HAVING TO BE SENT TO IR FOR REMOVAL. AFTER OBTAINING ACCESS TO THE VEIN WITHOUT ISSUE, THE GUIDEWIRE WAS INSERTED. THE GUIDEWIRE WAS ONLY ABLE TO BE INSERTED 6-10 CM IN. AN ATTEMPT TO REMOVE THE GUIDEWIRE WAS MADE BUT WAS NOT SUCCESSFUL. THE NEEDLE WAS REMOVED AND A SECOND ATTEMPT WAS MADE TO REMOVE THE GUIDEWIRE PULING THE LINE GENTLY, HOWEVER IT BEGAN TO FRAY AND COME UNRAVELED. THE ULTRASOUND WAS USED TO VISUALIZE THE GUIDEWIRE AND SHOWED IT INSIDE THE VESSEL BUT APPEARED TO HAVE DEVELOPED A KNOT AT THE END. AN INCISION WAS CREATED AND THE INTRODUCER INSERTED TO TRY TO CREATE A LARGER OPENING FOR THE GUIDEWIRE. THIS WAS UNSUCCESSFUL. THE WIRE WAS THEN COILED, THE INSERTION SITE DRESSED, AND THE MD WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720223 PRIMEPICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS PFM MEDICAL, INC. PFM2CT5D 1708-006 00813623013728

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention