BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREVI-XL/2

    MDR report key: 3807284 · Received March 20, 2014

    Report

    Report Number
    1316297-2014-00002
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 20, 2014
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    PMA / PMN Number
    954584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ON (B)(4) 2014, EPIMED EXAMINED THAT BREVI-XL/2 CATHETER IN QUESTION. DURING VISUAL INSPECTION, APPROXIMATELY 4.75" OF THE CATHETER'S OUTER TEFLON COATING WAS MISSING FROM THE CATHETER'S DISTAL END. FURTHERMORE, STARTING 4" FROM THE CATHETER'S DISTAL TIP, THE CATHETER'S FIRST LAYER OF COATING (PET) WAS SKIVED APPROXIMATELY 1 CM IN LENGTH WHICH EXPOSED THE CATHETER'S WOUND SPRING. THIS INDICATES THAT THE CATHETER HAD BECOME SEVERELY CAUGHT/PINCHED WITHIN THE PATIENT'S BONE STRUCTURE OR OTHER OBJECT. PER THE PHYSICIAN'S REPORTS OF THE EVENT, IT APPEARS THAT THE PATIENT'S ANATOMY WHICH CONTAINED "A LOT OF SCAR TISSUE" MAY HAVE MASKED THE SERIOUSNESS OF THE RESISTANCE THAT WAS BEING FELT BY THE PHYSICIAN. NONETHELESS, WHEN RESISTANCE WAS ENCOUNTERED, THE PHYSICIAN SHOULD HAVE REFERRED TO EPIMED'S INSTRUCTIONS FOR USE TO PREVENT ANY UNNECESSARY DAMAGE TO THE CATHETER.

    Description of Event or Problem · 1

    ON (B)(6) 2014, EPIMED'S QUALITY ASSURANCE DEPARTMENT WAS NOTIFIED OF AN EVENT THAT HAD RECENTLY OCCURRED INVOLVING EPIMED'S BREVI-XL/2, (CATALOG # 155-2342). THE CUSTOMER REPORTED "DURING RADIOFREQUENCY PERFORMANCE THROUGH VIA CAUDAL ROUTE OF NERVE ROOTS L5-S1, A CROSS-SECTION OF THE PLASTIC SHEATH SURROUNDING THE CATHETER OCCURS, LEAVING ABOUT 5 CM HOUSED IN THE PATIENT EPIDURAL SPACE". THE REPORTED STATUS OF THE PATIENT WAS GOOD. EPIMED RECOMMENDED THAT A NEUROSURGEON BE CONSULTED TO RETRIEVE THE SECTION OF CATHETER FROM THE PATIENT; HOWEVER, NO INFORMATION WAS PROVIDED FROM THE PHYSICIAN/HOSPITAL WHETHER A NEUROSURGEON HAD BEEN CONSULTED. THE PHYSICIAN STATED THAT THE PATIENT HAD ARTHRITIS WITH "A LOT" OF SCAR TISSUE, SO HE FELT RESISTANCE IN ALL MOMENTS, ADVANCEMENT, REMOVING ETC; AND HE THOUGHT THAT WAS THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167860 BREVI-XL/2 RACZ CATHETER BSO EPIMED INTERNATIONAL, INC. 155-2342 11425416

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK