BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUN-L-XL

    MDR report key: 7046710 · Received November 20, 2017

    Report

    Report Number
    1316297-2017-00009
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 10, 2017
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K954584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON OCTOBER 11, 2017, A COMPLAINT WAS RECEIVED BY EPIMED STATING THAT THEY HAD TWO RACZ CATHETERS THAT BEGAN TO FRAY WHEN THE DISTAL TIP OF THE CATHETER WAS INSERTED INTO THE NEEDLE. THEY ALSO STATED THAT THE DOCTOR WAS UNABLE TO ADVANCE (THE CATHETER) BECAUSE THEY IMMEDIATELY STARTED TO FRAY. ON OCTOBER 20, 2017, THE DEVICES ARRIVED AT EPIMED FOR EXAMINATION. DURING THIS EXAMINATION, IT WAS OBSERVED THAT APPROXIMATELY 2.5CM OF CATHETER FEP OUTER COATING WERE SHEARED OFF FROM BOTH OF THE RETURNED CATHETER'S DISTAL ENDS. THE REMAINING PORTION OF EACH RETURNED CATHETER REMAINED INTACT; I.E. NONE OF THE REMAINING SECTIONS OF CATHETER COATING WERE DAMAGED AND THE CATHETER'S INTERNAL SPRING AND BALL WELD REMAINED IN PLACE. ON OCTOBER 20, 2017, EPIMED INFORMED THE REPORTING ACCOUNT OF THE INVESTIGATIONAL FINDINGS. THE ACCOUNT COULD NOT ACCOUNT FOR THE MISSING PIECES OF CATHETER COATING. BECAUSE OF THIS, EPIMED RECOMMENDED THAT THE PATIENT SEE A NEUROSURGEON TO DETERMINE IF THE COATING REMAINED IN THE PATIENT. ON (B)(6) 2017, THE ACCOUNT REPORTED TO EPIMED THAT THE PATIENT HAD UNDERGONE A CT SCAN AND THAT A POSSIBLE FOREIGN BODY WAS DISCOVERED. ON (B)(6) 2017, THE REPORTING ACCOUNT PROVIDED EPIMED WITH THE RESULTS SUMMARY OF THE CT SCAN. THE SUMMARY READ IN PART, "FAINT LINEAR DENSITY WAS LOCATED WITHIN THE MOST DISTAL ASPECT OF THE SPINAL CANAL EXTENDING FROM THE PATIENT'S S3-4 JUNCTION TO THE MID AS 5 LEVEL". THE REPORT STATED THAT THE SUSPECTED FOREIGN BODY THAT WAS LOCATED WITHIN THE PATIENT'S EPIDURAL SPACE MEASURED APPROXIMATELY 3.2CM IN CEPHALOCAUDAL DIMENSION AND 1-2MM IN DIAMETER. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME REGARDING PATIENT OR PROCEDURE STATUS. HOWEVER, DUE TO THE NATURE OF THE REPORTED EVENT, EPIMED WILL FOLLOW UP WITH THE ACCOUNT FOR A PERIOD OF THREE MONTHS TO ENSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A COMPLAINT WAS RECEIVED BY EPIMED STATING THAT THEY HAD TWO RACZ CATHETERS THAT BEGAN TO FRAY WHEN THE DISTAL TIP OF THE CATHETER WAS INSERTED INTO THE NEEDLE. THEY ALSO STATED THAT THE DOCTOR WAS UNABLE TO ADVANCE (THE CATHETER) BECAUSE THEY IMMEDIATELY STARTED TO FRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826380 TUN-L-XL CATHETER BSO EPIMED INTERNATIONAL INC. A-EP-089 31428042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other