BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREVI-KATH

    MDR report key: 4798374 · Received May 26, 2015

    Report

    Report Number
    1316297-2015-00002
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 7, 2015
    Report Date
    May 15, 2015
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    PMA / PMN Number
    954584
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05/01/2015, EPIMED'S (B)(4) RECEIVED AN EMAIL FROM A PATIENT WHO WAS INVOLVED IN A PROCEDURE WHERE A PIECE OF THE BREVI-KATH CATHETER HAD SHEARED OFF WITHIN HER UPON REMOVAL. THE PATIENT STATED WITHIN HER EMAIL TO EPIMED THAT THE REMAINING PIECE OF CATHETER WILL HAVE TO BE SURGICALLY REMOVED. THE PATIENT WAS INITIALLY SEEKING A REIMBURSEMENT FOR THE SHEARED BREVI-KATH CATHETER. THIS REQUEST WAS CONSIDERED UNUSUAL; THEREFORE IT WAS FURTHER INVESTIGATED BY EPIMED'S QA MANAGER. DURING THE INVESTIGATION EPIMED WAS INFORMED BY DR. (B)(6) (PATIENT'S PHYSICIAN) THAT THE PATIENT HAD BEEN INVOLVED IN A PROCEDURE HE PERFORMED WHERE APPROXIMATELY 4 CM OF BOTH THE COATING AND THE INTERNALLY WOUND SPRING HAD SHEARED OFF AND WAS LEFT HOUSED WITHIN THE PATIENT. EPIMED HAS SINCE REACHED OUT TO THE PHYSICIAN WHO PERFORMED THE PROCEDURE SEEKING ADDITIONAL INFORMATION. HOWEVER, THE PHYSICIAN DOES NOT FEEL COMFORTABLE ANSWERING THE QUESTIONS REQUESTED OF HIM. THE PHYSICIAN STATED THAT HE IS AWAITING DIRECTION AND GUIDANCE FROM HIS ADMINISTRATION ON HOW TO PROCEED. EPIMED HAS CONFIDENCE THAT IF THE IFU PI-004 REV. 4 (SPRING GUIDE EPIDURAL CATHETER PRODUCT) WAS ADHERED TO, DAMAGE TO THE CATHETER COULD HAVE BEEN PREVENTED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CERVICAL ESI PROCEDURE (T1-T2) WAS BEING PERFORMED WITH A BREVI-KATH AND RK NEEDLE. DURING REMOVAL, THE CATHETER SHEARED LEAVING A PORTION OF BOTH THE CATHETER'S COATING AND SPRING (APPROXIMATELY 4 CM) HOUSED WITHIN THE PATIENT. THE PRODUCT IN QUESTION WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340335 BREVI-KATH RACZ CATHETER BSO EPIMED INTERNATIONAL, INC. 155-2393 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK