BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA-KATH

    MDR report key: 8768957 · Received July 8, 2019

    Report

    Report Number
    1316297-2019-00002
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 3, 2019
    Manufacturer
    EPIMED INTERNATIONAL INC
    Product Code
    BSO
    UDI-DI
    00818788021120
    PMA / PMN Number
    K023140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019, (B)(6), MANAGING DIRECTOR AT (B)(6), EMAILED EPIMED REGARDING A SHEARED PORTION OF CATHETER COATING THAT WAS LEFT WITHIN THE PATIENT AT LEVEL C3. THE DOCTOR STATED THAT HE PULLED THE CATHETER TO HARD AGAINST THE NEEDLE WHEN ATTEMPTING TO REPOSITION THE CATHETER. THE ACCOUNT STATED THAT APPROXIMATELY 10 CM OF THE CATHETER COATING WAS MISSING FROM THE DEVICE. THE REPORTING ACCOUNT PROVIDED EPIMED WITH PICTURES OF THE DEVICE AFTER THE REPORTED EVENT. EPIMED CONDUCTED MEASUREMENT ANALYSIS ON THE PICTURES AND DETERMINED THAT NONE OF THE CATHETER'S INTERNAL SPRING WAS MISSING FROM THE DEVICE, AND ALSO CONFIRMED THAT APPROXIMATELY 9-10 CM OF THE CATHETER COATING WAS MISSING. THE COATING OF THE VERSA-KATH CATHETER IS FLUORINATED ETHYLENE PROPYLENE (FEP), AND HAS BEEN SHOWN TO BE BIOCOMPATIBLE IN EPIMED'S TESTING. NO OTHER INFORMATION HAS BEEN PROVIDED BY THE REPORTING ACCOUNT AS OF JUNE 3, 2019. EPIMED WILL CONTINUE TO FOLLOW-UP WITH THE REPORTING ACCOUNT FOR A PERIOD OF THREE MONTHS FOR ANY PATIENT UPDATES.

    Description of Event or Problem · 1

    ON (B)(6) 2019, (B)(6), MANAGING DIRECTOR AT (B)(6), EMAILED EPIMED REGARDING A SHEARED PORTION OF CATHETER COATING THAT WAS LEFT WITHIN THE PATIENT AT LEVEL C3. THE DOCTOR STATED THAT HE PULLED THE CATHETER TO HARD AGAINST THE NEEDLE WHEN ATTEMPTING TO REPOSITION THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559916 VERSA-KATH CATHETER BSO EPIMED INTERNATIONAL INC A-EP-042 UNK 00818788021120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other