BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-MED II BALLOON DILATATION CATHETER

    MDR report key: 2625808 · Received August 18, 2008

    Report

    Report Number
    1318694-2008-00002
    Event Type
    Other
    Date Received
    August 18, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 18, 2008
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    PMA / PMN Number
    K030589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RECEIVED BY NUMED ON (B)(4) 2008. THE SPECIFICATIONS WERE NOT ABLE TO BE CHECKED DUE TO THE CONDITION OF THE CATHETER WHEN IT WAS RECEIVED. THE CATHETER WAS EXTREMELY BLOODY AND WAS DRIED TO THE ARROW SHEATH. THE BALLOONS APPEAR TO BE INTACT UPON VISUAL EXAMINATION, AND THERE WAS FLUID IN THE BALLOONS. THIS DEVICE WAS USED OFF-LABEL FOR STENT REDILATION. THERE IS A SPECIFIC WARNING IN THE INSTRUCTIONS FOR USE THAT THIS DEVICE IS NOT INTENDED FOR REDILATION OF STENTS. ALL CATHETERS MANUFACTURED FOR BRAUN UTILIZE A LABEL STATING THAT THE RECOMMENDED USE AND TESTING HAS BEEN DONE THROUGH A BRAUN SHEATH. IN THIS CASE, AN ARROW SHEATH WAS USED. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. VISUAL EXAMINATION. OTHER - USED OFF-LABEL EVEN WHEN THERE IS A SPECIFIC WARNING IN THE IFU THAT IT IS NOT INTENDED FOR THAT INDICATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT A STENT AND BALLOON DILATION OF THE AORTA COARCTATION PROCEDURE INVOLVING A GENESIS PG2510B STENT MOUNTED ON A 14-3 BIB BALLOON. RE-DILATION OCCURRED WITH A 16-3 Z-MED II BALLOON AND A 9 FRENCH ARROW FLEX SHEATH. BOTH DILATIONS WERE WITHOUT COMPLICATIONS. AFTER THE PROCEDURE THE PHYSICIAN WAS UNABLE TO REMOVE THE Z-MED II BALLOON BACK THROUGH THE SHEATH DESPITE MULTIPLE DEFLATIONS/ATTEMPTS. AS A RESULT, THE BALLOON WAS REMOVED THROUGH THE FEMORAL ARTERY USING A SURGICAL (CUT-DOWN) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-MED II BALLOON DILATATION CATHETER PTV CATHETER DQY NUMED, INC. PDZ648 ZZ-2982

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention