BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT STIFFENED DILATOR MINI ACCESS KITS

    MDR report key: 2130426 · Received June 14, 2011

    Report

    Report Number
    1721504-2011-00207
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DRE
    PMA / PMN Number
    K031691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SUSPECT DEVICE AND SEVENTEEN UNUSED DEVICES WERE RETURNED FOR EVALUATION. UPON VISUAL EXAMINATION, THE COMPLAINT WAS CONFIRMED. THE SHEATH MATERIAL WAS BROKEN NEAR THE HUB. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE UNUSED DEVICES WERE PERFORMANCE TESTED. ALL DEVICES TESTED MET THE ACCEPTANCE CRITERIA. THE ROOT CAUSE OF THE COMPLAINT IS ATTRIBUTED TO PATIENT CONDITION AND USER HANDLING OF THE DEVICE DURING REMOVAL. METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED. RESULTS: PHYSICIAN STATED THAT THE DEVICE WAS NOT AT FAULT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE ATTEMPTING TO REMOVE THE INTRODUCER, THERE WAS A FEELING OF RESISTANCE AND THE DEVICE GOT STUCK. THE PROCEDURE WAS BEING PERFORMED ON A PATIENT WITH TORTUOUS ANATOMY AND SCARRING. THE CUSTOMER REPORTED THAT THEY ATTEMPTED TO REMOVE THE DEVICE WITH A SLIGHT TWISTING AND PULLING MOTION. IT WAS THEN THAT THE SHEATH MATERIAL BROKE APPROXIMATELY 1/2 INCH DISTAL TO THE HUB. THE CUSTOMER TRIED TO REMOVE THE SHEATH MATERIAL WITH FORCEPS. WHEN THIS WAS UNSUCCESSFUL, A SECOND PHYSICIAN WAS CALLED IN TO REMOVE THE REMAINING SHEATH MATERIAL VIA CONTRALATERAL ACCESS WITH A SNARE. THE SHEATH MATERIAL WAS SUCCESSFULLY REMOVED. THE SECOND PHYSICIAN STATED THAT HE FELT THAT THE FAILURE WAS DUE TO THE PATIENT'S ANATOMY, NOT A PROBLEM WITH THE DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT STIFFENED DILATOR MINI ACCESS KITS DILATOR, VESSEL, CATHETERIZATION DRE MERIT MEDICAL SYSTEMS, INC. H229600

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R EN SNARE