BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4F-80CM PREM SYNTEL CATHETER

    MDR report key: 2861759 · Received November 26, 2012

    Report

    Report Number
    2027111-2012-00357
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 26, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    DXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    "DURING A PLANNED THROMBECTOMY/EMBOLECTOMY OF THE PT'S LEFT CFA/PFA/SFA THE CATHETER BECAME STUCK IN THE VESSEL. ANOTHER CONSULTANT VASCULAR SURGEON WAS ABLE TO PULL THE CATHETER OUT BUT THE TIP OF THE CATHETER HAD BECOME DETACHED AND REMAINED IN THE PT. DETAILS OF INJURY (TO PT, CARER OR HEALTH PROFESSIONAL): THE TIP OF THE CATHETER REMAINS IN THE PT. BLOOD FLOW WAS DEEMED SATISFACTORY." PT STATUS: "FOLLOWING THE PROCEDURE, THE PT WAS INFORMED BY THE CONSULTANT WHAT HAS HAPPENED. THE PT WAS ADMITTED TO HIGH DEPENDENCY UNIT FOR OBSERVATION. OTHER CATHETERS OF THE SAME BATCH ARE QUARANTINED IN THEATRES." PT STATUS UPDATE (B)(6) 2012 - THE PT HAS BEEN DISCHARGED FROM THE HOSPITAL AND WILL BE FOLLOWED UP IN A FEW WEEKS. THERE IS NO INDICATION FOR FURTHER SURGERY AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4F-80CM PREM SYNTEL CATHETER NONE DXE APPLIED MEDICAL CE0480ST TBD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R