BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTEL EMBOLECTOMY CATHETER, 4F, 80CM

    MDR report key: 1141352 · Received August 28, 2008

    Report

    Report Number
    2027111-2008-00040
    Event Type
    Other
    Date Received
    August 28, 2008
    Date of Event
    July 27, 2008
    Report Date
    August 26, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE TIP OF THE RETURNED CATHETER, FROM BALLOON MIDSECTION ONWARD, WAS MISSING. THIS CONFIRMED THE CLINICIAN'S STATEMENT THAT, DURING HIS SECOND INSERTION, HE HAD TO CUT THE CATHETER TO COMPLETE THE PROCEDURE. IT IS UNCLEAR WHY THE CATHETER COMPLETED ITS FIRST PASS SUCCESSFULLY ONLY TO BE TRAPPED IN THE VESSEL ON THE SECOND PASS. THE ROOT CAUSE OF THE MALFUNCTION CAN NOT BE DETERMINED DUE TO A LACK OF INFORMATION RELATED TO THE CONDITIONS SURROUNDING THE EVENT. THIS DOCUMENT REPRESENTS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    "THIS EMBOLECTOMY CATHETER WAS USED TO REMOVE BLOOD CLOT. IN THE 2ND USE FOR THIS PATIENT, THEY FELT RESISTANCE AND COULDN'T REMOVE THE CATHETER. THE SPRING TIP OF THE CATHETER WAS STRETCHED AND THE USER CUT THE PART WITH SCISSORS. THE REMAINING PART WAS LEFT IN THE PATIENT'S LEFT LEG BECAUSE THE PATIENT'S LEFT LEG WAS PLANNED TO BE CUT OFF .THIS INCIDENT HASN'T AFFECTED THIS PATIENT YET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTEL EMBOLECTOMY CATHETER, 4F, 80CM EMBOLECTOMY CATHETER DXE APPLIED MEDICAL RESOURCES A4F05 1054030

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization