BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROL

    MDR report key: 7814105 · Received August 24, 2018

    Report

    Report Number
    1316297-2018-00008
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Date of Event
    July 24, 2018
    Report Date
    August 24, 2018
    Manufacturer
    EPIMED INTERNATIONAL INC
    Product Code
    BSO
    UDI-DI
    00818788022264
    PMA / PMN Number
    K981329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 24, 2018, THE ACCOUNT REPORTED TO EPIMED THAT THE TIP OF THE CATHETER WAS RETAINED WITHIN THE PATIENT UPON CATHETER REMOVAL. THE ACCOUNT REPORTED THAT APPROXIMATELY 1.5 CM OF THE CATHETER REMAINED IN THE CAUDAL SPACE. UPON RETURN TO EPIMED, THE CATHETER WAS EXAMINED. THE TIP OF THE CATHETER APPEARED TO BE MISSING FROM THE DEVICE. MEASUREMENT TESTING WAS CONDUCTED, AND IT WAS DETERMINED THAT APPROXIMATELY 2 CM OF THE CATHETER'S DISTAL TIP WAS SHEARED. THE CATHETER WAS EXAMINED USING THE CE-180 (RAM OPTICAL MEASUREMENT SYSTEM). DURING THIS EXAMINATION, IT WAS NOTICED THAT THE SHEARED PORTION OF THE CATHETER APPEARED ROUGH IN TEXTURE. THE CATHETER DID NOT APPEAR TO BE CUT AS WOULD BE EXPECTED IF THE CATHETER WERE WITHDRAWN AGAINST A NEEDLE TIP. THE REPORTING ACCOUNT STATED THAT THEY WERE USING A BECTON DICKINSON ANGIOCATH DEVICE IN CONJUNCTION WITH THE EPIMED CATHETER DURING THE REPORTED PROCEDURE. THE ANGIOCATH IS DESIGNED FOR THE END-USER TO FIRST REMOVE AN INTRODUCER NEEDLE FROM A PLASTIC CANNULA BEFORE INSERTING THE CATHETER THROUGH THE PLASTIC CANNULA AND INTO THE PATIENT. IT IS HIGHLY UNLIKELY THAT THE CATHETER BECAME SHEARED THROUGH AN INTERACTION WITH THE CANNULA OF AN ANGIOCATH. THE REPORTING ACCOUNT DID NOT RETURN THE REPORTED ANGIOCATH TO EPIMED FOR EXAMINATION AND EPIMED DID NOT CONDUCT TESTING ON AN ANGIOCATH DEVICE. HOWEVER, EPIMED DOES MANUFACTURE A BLUNT ACCESS CANNULA (BAC), WHICH IS SIMILAR IN DESIGN TO BECTON DICKINSON'S ANGIOCATH. BECAUSE OF THIS, SKIVE TESTING WAS CONDUCTED ON THE RETURNED CATHETER USING AN EPIMED BAC. THE CATHETER DID NOT SKIVE DURING THIS TESTING. BASED ON ALL AVAILABLE EVIDENCE, EPIMED COULD NOT DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED COMPLAINT. HOWEVER, EPIMED SUSPECTS THAT THE CATHETER IN QUESTION MAY HAVE BECOME CAUGHT ON SCAR TISSUE OR AN INTERNAL STRUCTURE DURING THE PROCEDURE AND SUBSEQUENTLY BECAME DAMAGED. AS OF (B)(6) 2018, THE REPORTING ACCOUNT STATED THAT THE PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    THE TIP OF THE CAUDAL CATHETER WAS RETAINED IN THE PATIENT UPON CATHETER REMOVAL. ABOUT 1.5 CM OF THE CATHETER TIP REMAINS IN THE CAUDAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656155 SPIROL CATHETER BSO EPIMED INTERNATIONAL INC A-EP-407 16368577 00818788022264

    Patients

    Seq Age Sex Outcome Treatment
    1 Other