BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-KATH

    MDR report key: 8298857 · Received February 1, 2019

    Report

    Report Number
    1316297-2019-00001
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    October 1, 2018
    Report Date
    January 30, 2019
    Manufacturer
    EPIMED INTERNATIONAL INC
    Product Code
    BSO
    UDI-DI
    00818788021397
    PMA / PMN Number
    K023140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019, (B)(6) EMAILED EPIMED STATING THAT THEY HAD AN ACCOUNT THAT REPORTED THE PET INNER COATING (B-TU-005) ON TWO DIFFERENT VERSA-KATH CATHETERS WAS DIFFERENT IN LENGTH. MR. (B)(6) STATED THAT THE REPORTING HOSPITAL HAD USED ONE OF THE VERSA-KATH'S DURING A PROCEDURE AND THAT THE PATIENT BECAME NEUROLEPSIS. THE PHYSICIAN STATED THAT "IF THE GRAY (PET) COATING IS SHORTENED, IT IS HARD TO REACH THE TARGET, SO IT BENDS IN THE BODY AND TOUCHES OTHER NERVES WHEN TARGETING." MR. (B)(6) STATED THAT (B)(6) HAD RECEIVED TWO SAMPLE CATHETERS FROM THE REPORTING HOSPITAL FOR COMPARISON ANALYSIS OF THE PET COATING. ONE CATHETER SAMPLE WAS A 12" VERSA-KATH (LOT 11128891) AND THE SECOND CATHETER SAMPLE WAS A 24" VERSA-KATH (LOT 11248832). MR. (B)(6) PROVIDED A PICTURE OF THE TWO DEVICES TO EPIMED.. AFTER REVIEW OF THE SUPPLIED PICTURE, IT WAS EVIDENT THAT THE GRAY PET COATING LENGTH BETWEEN THE TWO DEVICES DIFFERED IN LENGTH. HOWEVER, VERSA-KATH SPECIFICATIONS, A TOLERANCE OF UP TO .50" IS ALLOWED BETWEEN THE DISTAL END OF THE CATHETER'S PET COATING AND THE PROXIMAL END OF THE CATHETER'S DISTAL SPREAD. THEREFORE, THE LENGTHS OF THE PET COATING CAN DIFFER BETWEEN DIFFERENT CATHETERS AND/OR CATHETER LOTS. THE BATCH HISTORY RECORDS FOR THE REPORTED CATHETER LOTS WERE IMMEDIATELY REVIEWED; REVEALING NO ABNORMALITIES WITHIN THE REPORTED LOTS. ALL INSPECTION AND TESTING PASSED SUCCESSFULLY. THE PET COATING IS SUPPLIED TO EPIMED. A REVIEW OF THE SUPPLIER FILES ALONG WITH REVIEW OF PREVIOUS REVISIONS OF THE PRODUCT SPECIFICATIONS FOR THE PET COATING REVEALED NO CHANGES MADE IN REGARD TO COATING MATERIAL OR COATING WALL THICKNESS. AFTER RECEIPT OF THE MR. (B)(6)'S EMAIL, EPIMED IMMEDIATELY MR. (B)(6) AND REQUESTED THE CATHETER SAMPLES TO BE RETURNED TO EPIMED FOR MEASUREMENT TESTING. HOWEVER, NO RESPONSE TO THE EMAIL WAS RECEIVED. A FOLLOW-UP EMAIL WAS SENT TO MR. (B)(6) ON JANUARY 31, 2019 REQUESTING ANY ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT; HOWEVER, AS OF FEBRUARY 1, 2019, NO RESPONSE OR ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT WAS RECEIVED BY EPIMED. NEXT, THE PREVIOUS 5 YEARS OF COMPLAINT HISTORY WAS ELECTRONICALLY REVIEWED FOR SIMILAR COMPLAINTS; HOWEVER, NO SIMILAR COMPLAINTS WERE FOUND. THE REPORTING ACCOUNT STATED THAT THE PATIENT HAD EXPERIENCED NEUROLEPSIS AND THE PHYSICIAN REPORTED THAT IT WAS DUE TO THE DIFFERING LENGTHS OF CATHETER COATING. AS A PRECAUTIONARY MEASURE, EPIMED HAS FILED THIS MDR REGARDING THE REPORTED EVENT. DUE TO THE FACT THAT THE REPORTED DEVICES WERE NOT RETURNED TO EPIMED FOR TESTING, A MORE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON ALL AVAILABLE EVIDENCE, EPIMED SUSPECTS THAT END-USER ERROR LED TO THE REPORT OF NEUROLEPSIS OF THE PATIENT; NOT THE DESIGN OF THE CATHETER. EPIMED WILL FOLLOW-UP WITH THE REPORTING ACCOUNT FOR A PERIOD OF TWO MORE MONTHS IN AN ATTEMPT TO ACQUIRE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    "THE HOSPITAL INFORMED US THAT GRAY COATING PART OF THE TWO PRODUCTS IS DIFFERENT FROM THE OLDER VERSIONS. SO, WE RANDOMLY CHECKED THESE PRODUCTS IN THE BOX AND WE FOUND THAT THE GRAY COATING OF THE OLD VERSION'S PRODUCT IS COVERED UP TO THE FRONT OF THE SPRING, BUT THE LATEST VERSION'S GRAY COATING IS IRREGULAR LENGTH. SOME ARE SHORT AND SOME ARE LONG, WE CANNOT FIGURE OUT HOW MANY QUANTITIES ARE DIFFERENT FROM OLDER VERSION. SERIOUSLY, THE HOSPITAL IS FACED WITH AN UNEXPECTED SERIOUS SITUATION NOW. THE PATIENT BECAME NEUROLEPSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92483 VERSA-KATH CATHETER BSO EPIMED INTERNATIONAL INC A-EP-042 11128891 00818788021397

    Patients

    Seq Age Sex Outcome Treatment
    1 Other