BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA-KATH CATHETER

    MDR report key: 6151135 · Received December 7, 2016

    Report

    Report Number
    1316297-2016-00020
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 4, 2016
    Report Date
    December 2, 2016
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K023140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 4, 2016, EPIMED RECEIVED A CALL FROM (B)(6), REPORTING AN INCIDENT INVOLVING A SHEARED VERSA-KATH CATHETER. A 7CM FRAGMENT OF THE CATHETER WAS RETURNED TO EPIMED ON NOVEMBER 9, 2016. THE CATHETER FRAGMENT WAS CLOSELY EXAMINED UNDER THE CE-180 (RAM OPTICAL MEASUREMENT SYSTEM). IT APPEARED THAT THE CATHETER HAD BEEN CUT BY AN EXTERNAL FORCE; HOWEVER, EPIMED DETERMINED THIS TO BE INCONCLUSIVE BASED ON THE VISUAL EVIDENCE ALONE. ON NOVEMBER 11, 2016, EPIMED'S QA ANALYST EMAILED SUSAN USSERY WITH ADDITIONAL QUESTIONS REGARDING THE INITIAL REPORTED COMPLAINT. ACCORDING TO THE PHYSICIAN, WHILE PERFORMING A CERVICAL PAIN PROCEDURE, SOME RESISTANCE WAS EXPERIENCED WHILE INSERTING THE CATHETER. HE STATED THAT HE WAS USING A CAUDAL APPROACH, AND WAS ATTEMPTING TO POSITION THE CATHETER USING THE FLUOROSCOPE, BUT WAS EXPERIENCING DIFFICULTY. HE STATED THAT HE ATTEMPTED TO WITHDRAW THE CATHETER, BUT MET RESISTANCE. HE WITHDREW THE NEEDLE, AND THEN THE CATHETER, AND THAT IS WHEN HE NOTICED THE DEFECT. ALTHOUGH A PATIENT WAS INVOLVED AT THE TIME OF THE REPORTED INCIDENT, NO ADVERSE EVENTS OR HARM OCCURRED DURING THE PROCEDURE. THE SHEARED CATHETER FRAGMENT WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY, AND THE PROCEDURE WAS EVENTUALLY COMPLETED SUCCESSFULLY WITH A NEW CATHETER AND A NEW RX COUDE NEEDLE. EPIMED SUSPECTS THAT END-USER ERROR CAUSED THE SHEAR TO THE VERSA-KATH CATHETER. IN RESPONSE TO EPIMED'S QUESTIONS REGARDING THE REPORTED COMPLAINT, THE PHYSICIAN STATED THAT HE ATTEMPTED TO WITHDRAW THE CATHETER FIRST, BUT MET RESISTANCE. EPIMED WARNS AGAINST THIS WITHIN THEIR IFU PI-004 REV. 3. EPIMED BELIEVES IF THE IFU WAS FOLLOWED, IT MAY HAVE PREVENTED THE DAMAGE TO THE CATHETER IN QUESTION. EPIMED ALSO ELECTRONICALLY REVIEWED 5 YEARS OF PREVIOUS COMPLAINT HISTORY, BUT DID NOT FIND ANY COMPLAINTS INVOLVING A FULLY SHEARED VERSA-KATH CATHETER. EPIMED BELIEVES THIS WAS AN ISOLATED INCIDENT AND A FAILURE OF THE END-USER TO PROPERLY FOLLOW THE DEVICE IFU.

    Description of Event or Problem · 1

    ON NOVEMBER 4, 2016, EPIMED'S QUALITY ASSURANCE MANAGER RECEIVED A CALL FROM (B)(6), MEDICAL LAB TECHNICIAN, AT (B)(6), REPORTING THAT, "WHILE THE DOCTOR WAS INSERTING THE CATHETER, THE CATHETER BROKE IN HALF. THE DOCTOR WAS ABLE TO REMOVE THE PIECE OF THE CATHETER FROM THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801840 VERSA-KATH CATHETER VERSA-KATH CATHETER BSO EPIMED INTERNATIONAL INC. A-EP-042 31127262

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR