BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA-KATH CATHETER

    MDR report key: 6230625 · Received January 6, 2017

    Report

    Report Number
    1316297-2016-00021
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    December 6, 2016
    Report Date
    January 6, 2016
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K023140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON DECEMBER 6, 2016, EPIMED RECEIVED A CALL FROM (B)(6), REPORTING AN INCIDENT INVOLVING A SHEARED VERSA-KATH CATHETER. THE CATHETER WAS RETURNED TO EPIMED ON DECEMBER 9, 2016. DURING EXAMINATION, IT WAS EVIDENT THE CATHETER'S FEP OUTER COATING HAD SHEARED NEAR THE DISTAL END. THE PET INNER COATING AND THE INTERNAL CATHETER SPRING REMAINED INTACT. HOWEVER, THE INTERNAL SPRING WAS STRETCHED AND UNCOILED. THE CATHETER'S COATING WAS SHEARED APPROXIMATELY 2.5" FROM THE CATHETER'S DISTAL END. THE PIECE OF COATING WAS NOT RETURNED TO EPIMED. THE CATHETER WAS CLOSELY EXAMINED UNDER THE CE-180 (RAM OPITCAL MEASUREMENT SYSTEM). DURING THIS EXAMINATION, IT WAS DISCOVERED THAT THE DIRECTION OF THE COATING SHEAR WAS FROM THE PROXIMAL END OF THE CATHETER TRACKING TOWARDS THE CATHETER'S DISTAL END. THIS IS INDICATIVE OF AN ATTEMPT TO REMOVE THE CATHETER WHILE THE CATHETER WAS EITHER STILL "LODGED" WITHIN THE PATIENT AND/OR WHILE THE NEEDLE WAS STILL POSITIONED WITHIN THE PATIENT; I.E. THE CATHETER MAY HAVE BECOME CAUGHT ON THE NEEDLE'S HEEL OF THE BEVEL/TIP DURING CATHETER WITHDRAWAL. DURING THE DESCRIPTION OF THE EVENT, DR. (B)(6) STATED THAT THE CATHETER HAD BEEN "INSERTED INTO S1 (L5-S1 LUMBOSACRAL JOINT), SNAGGED IN SCAR TISSUE, AND THE INTERNAL SPRING BECAME UNCOILED." DR. (B)(6) STATED HE DID NOT WITHDRAW ON THE CATHETER WHILE THE NEEDLE WAS STILL IN PLACE. HOWEVER, THE MANNER IN WHICH THE CATHETER'S COATING WAS SHEARED IS INDICATIVE OF THE CATHETER'S COATING BECOMING CUT WHILE BEING RETRACTED AGAINST A SHARP EXTERNAL FORCE. DR. (B)(6) STATED THAT HE WAS CONFIDENT THAT THE CATHETER COATING THAT HAD SHEARD OFF DURING THE PROCEDURE (DUE TO BEING SNAGGED) AND HAD BEEN LEFT INSIDE THE PATIENT. DR. (B)(6) STATED HE WOULD NOTIFY THE PATIENT OF THE FINDINGS AND CONTINUE TO OBSERVE THE PATIENT FOR ANY ADVERSE REACTIONS RELATED TO THE INCIDENT. EPIMED SUSPECTS THAT THE CATHETER BECAME CAUGHT ON THE NEEDLE'S HEEL OF THE BEVEL/TIP, POSSIBLY DURING AN ATTEMPT TO REPOSITION OR INADVERTENT RETRACTION BY THE PHYSICIAN. EPIMED WARNS AGAINST THIS IN THEIR IFU PI-004 REV. 3. EPIMED BELIEVES IF THE IFU WAS FOLLOWED, IT MAY HAVE PREVENTED THE DAMAGE TO THE CATHETER IN QUESTION.

    Description of Event or Problem · 1

    ON DECEMBER 6, 2016, (B)(6) RADIOLOGY TECHNICIAN, (B)(6), CONTACTED EPIMED'S QUALITY ASSURANCE DEPARTMENT ON BEHALF OF DR. (B)(6); REPORTING THAT DURING A PROCEDURE, THE CATHETER WAS INSERTED INTO S1, SNAGGED IN SCAR TISSUE, AND THE INTERNAL SPRING BECAME UNCOILED. THE PROCEDURE WAS EVENTUALLY COMPLETED SUCCESSFULLY. THE ACCOUNT REQUESTED NOTIFICATION IF ANY OF THE CATHETER MATERIAL WAS DETERMINED MISSING DURING EPIMED'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11523 VERSA-KATH CATHETER VERSA-KATH CATHETER BSO EPIMED INTERNATIONAL INC. A-EP-042 11127443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other