BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREVI-XL/2

    MDR report key: 7838570 · Received August 31, 2018

    Report

    Report Number
    1316297-2018-00009
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    July 30, 2018
    Report Date
    August 30, 2018
    Manufacturer
    EPIMED INTERNATIONAL INC
    Product Code
    BSO
    UDI-DI
    00818788021069
    PMA / PMN Number
    K954584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON AUGUST 8, 2018, EPIMED RECEIVED NOTIFICATION OF AN INCIDENT INVOLVING A SHEARED 18G BREVI-XL/2 CATHETER FROM (B)(6). THE ACCOUNT STATED THAT THE PHYSICIAN USED A 16 GA EPIMED INTRODUCING NEEDLE VIA THE S1 FORAMEN TO TARGET SCARRING NEAR L5/S1. WHEN THE PHYSICIAN ENTERED THE S1 FORAMEN, THE TIP OF THE CATHETER GOT STUCK IN THE DORSAL ASPECT OF THE S1 FORAMEN. DESPITE TUGGING ON THE CATHETER, THE PHYSICIAN WAS UNABLE TO DISLODGE IT. BECAUSE OF THIS, THE DECISION WAS MADE TO ATTEMPT TO RETRIEVE THE CATHETER TIP BY DISSECTING DOWN THE LENGTH OF THE CATHETER. SUBSEQUENTLY, THE TIP OF THE CATHETER BROKE OFF AND WAS IRRETRIEVABLE. THE DECISION WAS MADE TO TERMINATE THE PROCEDURE AND THE CATHETER TIP REMAINS IN SITU. THE ACCOUNT HAS REPORTED THAT THE PATIENT HAS BEEN EXAMINED FURTHER AND HAS HAD NO NEW RADICULAR SYMPTOMS AS A RESULT OF THIS REPORTED INCIDENT AND IS REPORTED TO BE DOING WELL. ALTHOUGH THE DEVICE WAS NOT AVAILABLE FOR RETURN TO EPIMED, A BATCH HISTORY RECORD REVIEW WAS CONDUCTED FOR THE LOT IN QUESTION; REVEALING NO ABNORMALITIES WITHIN THE REPORTED LOT RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    ON AUGUST 8, 2018, EPIMED RECEIVED NOTIFICATION OF AN INCIDENT INVOLVING A SHEARED 18G BREVI-XL/2 CATHETER FROM (B)(6). THE ACCOUNT STATED THAT THE PHYSICIAN USED A 16 GA EPIMED INTRODUCING NEEDLE VIA THE S1 FORAMEN TO TARGET SCARRING NEAR L5/S1. WHEN THE PHYSICIAN ENTERED THE S1 FORAMEN, THE TIP OF THE CATHETER GOT STUCK IN THE DORSAL ASPECT OF THE S1 FORAMEN. DESPITE TUGGING ON THE CATHETER, THE PHYSICIAN WAS UNABLE TO DISLODGE IT. BECAUSE OF THIS, THE DECISION WAS MADE TO ATTEMPT TO RETRIEVE THE CATHETER TIP BY DISSECTING DOWN THE LENGTH OF THE CATHETER. SUBSEQUENTLY, THE TIP OF THE CATHETER BROKE OFF AND WAS IRRETRIEVABLE. THE DECISION WAS MADE TO TERMINATE THE PROCEDURE AND THE CATHETER TIP REMAINS IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677991 BREVI-XL/2 CATHETER BSO EPIMED INTERNATIONAL INC A-EP-086 11428257 00818788021069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other