BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G SPIROL

    MDR report key: 7639362 · Received June 26, 2018

    Report

    Report Number
    1316297-2018-00007
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Date of Event
    April 16, 2018
    Report Date
    June 26, 2018
    Manufacturer
    EPIMED INTERNATIONAL INC
    Product Code
    BSO
    UDI-DI
    00818788021649
    PMA / PMN Number
    K981329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ARRIVAL, THE CATHETER WAS DECONTAMINATED PER SOP-021 (HANDLING BIOLOGICALLY CONTAMINATED PRODUCT). AFTER DECONTAMINATION, THE RETURNED DEVICES WERE EXAMINED. THE 20G SPIROL CATHETER IN QUESTION WAS RETURNED FULLY INTACT. THE CATHETER WAS FULLY INSERTED INTO THE RETURNED STINGRAY CONNECTOR TO WHERE THE CATHETER'S PROXIMAL DEPTH MARK PROPERLY ALIGNED WITHIN THE CONNECTOR'S SHOVEL PORTION. A BROKEN TONGUE DEPRESSOR WAS ATTACHED WITH MEDICAL TAPE TO THE SPIROL CATHETER APPROXIMATELY 6" FROM THE CATHETERS PROXIMAL END. AN ORANGE PIECE OF TAPE WAS OBSERVED WRAPPED AROUND THE RETURNED STINGRAY CONNECTOR. ALSO, A KINK WAS OBSERVED IN THE CATHETER APPROXIMATELY 16" FROM THE CATHETERS PROXIMAL END. AFTER EXAMINATION, A FLOW TEST WAS CONDUCTED USING THE RETURNED DEVICES AND A SYRINGE FILLED WITH WATER. DURING FLOW TESTING, WATER COULD BE SEEN EXPELLING FROM THE CATHETER WALL AT THE LOCATION WHERE THE ABOVEMENTIONED KINK WAS OBSERVED. NEXT, THE KINK IN THE CATHETER WAS EXAMINED USING THE CE-180 (RAM OPTICAL MEASUREMENT SYSTEM). DURING THIS EXAMINATION, IT WAS EVIDENT THAT THE CATHETER'S INTERNAL SPRING WAS SEVERELY TWISTED AT THE LOCATION OF THE KINK. WHAT APPEARED TO BE A TEAR IN THE CATHETER WALL WAS ALSO OBSERVED DURING THIS EXAMINATION. EPIMED SUSPECTS THAT THE TONGUE DEPRESSOR THAT THE ACCOUNT HAD ATTACHED TO THE CATHETER USING MEDICAL TAPE COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. EPIMED WAS UNABLE TO GATHER INFORMATION RELATED TO WHY THE TONGUE DEPRESSOR WAS ATTACHED TO THE CATHETER. EPIMED SUSPECTS IT IS POSSIBLE THAT THE CATHETER MAY HAVE BECOME CAUGHT ON THE TONGUE DEPRESSOR AND SUBSEQUENTLY BECAME TANGLED AND/OR DAMAGED. HOWEVER, IT IS ALSO POSSIBLE THAT THE CATHETER BECAME TANGLED WHILE THE PATIENT WAS MOVING AND/OR ROLLING OVER THE CATHETER WHILE IT WAS STILL IN SITU. EPIMED DOES NOT RECOMMEND ANY MODIFICATION OF THE DEVICE(S) BY THE END-USER. EPIMED ONLY RECOMMENDS THE USE OF THE DEVICE(S) IN ACCORDANCE TO THE INSTRUCTIONS LISTED IN THE IFU. NEXT, THE BATCH HISTORY RECORDS WERE REVIEWED FOR THE LOT IN QUESTION. NO ABNORMALITIES RELATED TO THE REPORTED COMPLAINT WERE DISCOVERED DURING REVIEW OF THIS LOT. THE LOT PASSED ALL APPLICABLE INSPECTIONS AND TESTING. NEXT, THE PREVIOUS 5 YEARS OF COMPLAINT HISTORY WAS ELECTRONICALLY REVIEWED FOR SIMILAR COMPLAINTS; HOWEVER, NO SIMILAR COMPLAINTS WERE FOUND. BECAUSE OF THIS, EPIMED HAS DEEMED THIS COMPLAINT TO BE ISOLATED. HOWEVER, EPIMED WILL CONTINUE TO MONITOR ALL FUTURE SIMILAR COMPLAINTS FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    REMOVED AS PER PROTOCOL, HOWEVER HAD BEEN KINKED AND LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480892 20G SPIROL CATHETER BSO EPIMED INTERNATIONAL INC A-EP-029 1638558 00818788021649

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR