BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEPICC OR PRIMEMIDLINE

    MDR report key: 8228559 · Received January 8, 2019

    Report

    Report Number
    2032582-2018-00007
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    November 27, 2018
    Report Date
    January 8, 2019
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    LJS
    PMA / PMN Number
    K072391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    3 GOOD FAITH ATTEMPTS WERE MADE TO THE REPORTER TO GET ADDITIONAL INFORMATION ABOUT THE DEVICE (I.E. REF, LOT NUMBER). REPORTER DID NOT RESPOND TO THE REQUESTS. REPORTER DID ADDITIONALLY MENTION THAT THE GUIDEWIRE WAS ONLY ADVANCED 8 TO 10 CM INTO THE VESSEL AND NOTICED IT WOULDN'T PULL BACK. THE GUIDEWIRE APPEARED TO BE UNRAVELLING. THE AGUIDEWIRE IS SOURCED FROM ANOTHER SUPPLIER AND ARE UNABLE TO DETERMINE WHICH GUIDEWIRE AS THE EXACT PRODUCT USED HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    PICC OR MIDLINE WAS BEING PLACED AND GUIDEWIRE WAS UNABLE TO BE REMOVED THROUGH SHEATH DILATOR INCLUDING MULTIPLE ATTEMPTS FOLLOWING PARTIAL REMOVAL OF DILATOR. GUIDWEIRE WAS LEFT IN PLACE AND PATIENT REFERRED TO INTERVENTIONAL RADIOLOGY DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18781 PRIMEPICC OR PRIMEMIDLINE INTRAVASCULAR CATHETER LJS PFM MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention