BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIMED BREVI-XL RADIO-OPAQUE EPIDURAL CATHETER

    MDR report key: 6024254 · Received October 12, 2016

    Report

    Report Number
    1316297-2016-00019
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 26, 2016
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K954584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN, THE 19G BREVI-XL CATHETER WAS REVIEWED. THE CATHETER COATING WAS NOT SHEARED, BUT SKIVED, AND AS A RESULT, THE DISTAL TIP OF THE CATHETER WAS RETRACTED WITHIN THE FEP OUTER COATING. ALTHOUGH THE FEP PORTION OF THE CATHETER HAD BECOME SKIVED, ALL OF THE CATHETER COATING WAS INTACT AND ACCOUNTED FOR. DURING REVIEW OF THE IHR-022S (EPIMED INITIAL COMPLAINT FORM - SUPPLEMENTAL), THE PHYSICIAN STATED THAT SHE HAD DRAWN BACK ON THE CATHETER WHILE THE NEEDLE WAS IN PLACE. EPIMED'S IFU PI-004 REV. 3 WARNS AGAINST THIS. IT WAS OBSERVED THAT THE DIRECTION OF THE SKIVE WAS TRACKING FROM THE PROXIMAL END TOWARD THE DISTAL END OF THE CATHETER. THIS FINDING IS INDICATIVE OF AN ATTEMPT TO REMOVE THE CATHETER WHILE THE CATHETER WAS EITHER STILL "LODGED" WITHIN THE PATIENT AND/OR WHILE THE NEEDLE WAS STILL POSITIONED WITHIN THE PATIENT (I.E. THE CATHETER MAY HAVE BECOME CAUGHT ON THE NEEDLE'S HEEL OF THE BEVEL/TIP). THE CORRESPONDING 16G RX-2 COUDE NEEDLE WAS UNAVAILABLE FOR REVIEW AND HAD BEEN DISCARDED BY THE ACCOUNT. THE LOT NUMBER OF THE NEEDLE WAS NOT MADE AVAILABLE TO EPIMED. HOWEVER, THE BATCH HISTORY RECORDS FOR THE CATHETER AND THE POTENTIAL BHR'S FOR THE NEEDLE (BASED ON THE ACCOUNT'S SALES HISTORY) WERE REVIEWED, FINDING NO ABNORMALITIES WITHIN THE MANUFACTURING LOTS. EPIMED HAS REMINDED THE ACCOUNT TO PROPERLY REVIEW THE IFU FOR SPRING GUIDE EPIDURAL CATHETER PRODUCTS PRIOR TO FUTURE PROCEDURES. EPIMED BELIEVES IF THE IFU WAS FOLLOWED, IT MAY HAVE PREVENTED DAMAGE TO THE CATHETER IN QUESTION. THERE WAS NO PATIENT INJURY OR ADVERSE EVENTS REPORTED AS A RESULT OF THIS COMPLAINT.

    Description of Event or Problem · 1

    ON SEPTEMBER 14, 2016, EPIMED RECEIVED AN EMAIL FROM CLINICAL SALES CONSULTANT, (B)(6), WITH AN ATTACHED COMPLAINT FROM (B)(6) . THE COMPLAINT STATED, "AT THE START OF PROCEDURE, AFTER INTRODUCING THE CATHETER THROUGH THE RX-2 NEEDLE, I NOTICED THAT I COULDN'T ADVANCE THE CATHETER ABOVE L4/L5. I DECIDED TO REMOVE THE CATHETER OUT. THEN, I NOTICED A SHEARED CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671545 EPIMED BREVI-XL RADIO-OPAQUE EPIDURAL CATHETER EPIDURAL CATHETER BSO EPIMED INTERNATIONAL INC. A-EP-084 11407512

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR