BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREVI-KATH RADIO-OPAQUE EPIDURAL CATHETER

    MDR report key: 359533 · Received November 2, 2001

    Report

    Report Number
    MW1023302
    Event Type
    Malfunction
    Date Received
    November 2, 2001
    Date of Event
    November 2, 2001
    Report Date
    November 2, 2001
    Manufacturer
    EPIMED
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A RACZ PROCEDURE DONE, USING AN EPIMED BREVI-KATH RADIO-OPAQUE EPIDURAL CATHETER, LOT 1193620. AFTER PERFORMING ADHESIONOLYSIS, MD NOTED THAT THE CATHETER COULD NOT BE PULLED BACK. AS THE CATHETER WAS IN GOOD POSITION AND AS MD WAS CONCERNED THAT THE CATHETER WAS CATCHING ON THE NEEDLE AND THAT THE NEEDLE WOULD SHEAR IT OFF, MD REMOVED THE NEEDLE AND COMPLETED THE RACZ PROCEDURE WITHOUT INCIDENT. AFTER THE PROCEDURE, THE CATHETER COULD NOT EASILY BE PULLED OUT. THE PT WAS TAKEN BACK TO THE PROCEDURE ROOM AND THE CATHETER EXAMINED UNDER FLUOROSCOPY. THERE WERE NO KNOTS, KINKS OR OBVIOUS REASONS FOR OBSTRUCTION. A NEUROSURGEON WAS CONSULTED. MD AND NEUROSURGEON AGREED TO PULL ON THE CATHETER SHARPLY TO PULL IT OUT. THIS RESULTED IN THE CATHETER BREAKING, WITH THE REMAINING CATHETER EXTENDING FROM THE SACRAL CORNU TO JUST ABOVE THE L5-S1 DISC SPACE. THE DECISION WAS MADE TO COVER THE PT WITH ANTIBIOTICS AND FOLLOW THEM. X-RAY TECH MENTIONED AN IDENTICAL CATHETER BEING SHEARED OFF AT A NEIGHBORING FACILITY LAST WEEK. AS THESE CATHETERS ARE DESIGNED SPECIFICALLY FOR THIS TASK, MDS' CONCERN IS OF A DEFECTIVE BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49184 BREVI-KATH RADIO-OPAQUE EPIDURAL CATHETER EPIDURAL CATHETER FOR LYSIS OF ADHESIONS BSO EPIMED 155-2393 1193620

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other