BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM

    MDR report key: 1950223 · Received December 9, 2010

    Report

    Report Number
    3005188751-2010-00128
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 4, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K791129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT DESCRIPTION RECEIVED ON (B)(4) 2010 OF "THE WIRE COULD NOT PASS THROUGH THE NEEDLE", DID NOT MEET ADVERSE EVENT REPORTING CRITERIA. THE FINDINGS IN THE INVESTIGATION COMPLETED ON (B)(4) 2010 INDICATE THE EVENT IS A MALFUNCTION THAT COULD LEAK TO DEATH OR SERIOUS INJURY IF IT WERE TO REOCCUR. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE GUIDEWIRE WAS STUCK WITHIN THE LUMEN OF THE NEEDLE'S CANNULA. AFTER REMOVING THE GUIDEWIRE IT WAS NOTED THE NEEDLE HAD SOMETHING LODGED WITHIN THE LUMEN. THE NEEDLE WAS SOAKED FOR SEVERAL DAYS WHICH SOFTENED THE BLOCKAGE ENOUGH FOR IT TO EXIT THROUGH THE DISTAL END OF THE PUNCTURE NEEDLE. THE RESIDUAL MATTER THAT CAME OUT OF THE DISTAL END OF THE PUNCTURE NEEDLE WAS SOAKED IN WARM WATER FOR 24 HOURS. THE MATERIAL DISSOLVED COMPLETELY AND NOTHING WAS FOUND WITHIN THE BEAKER THAT HOUSED THE RESIDUAL MATTER. THE SOURCE OF THE BLOCKAGE MATERIAL IS UNK. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. DATE REPORT SUBMITTED TO FDA BY MFR: 12/09/2010. DATE THE INITIAL REPORTER PROVIDE THE INFO TO THE MFR: (B)(4) 2010. DATE INVESTIGATION COMPLETED: 12/07/2010.

    Description of Event or Problem · 1

    INVESTIGATION OF A RETURNED PUNCTURE NEEDLE AND GUIDEWIRE REVEALED A BLOCKAGE OF UNK MATERIAL IN THE PUNCTURE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM PEEL-AWAY, 7F TW, DI-LO DQX ST. JUDE MEDICAL, AF DIVISION 405154 3131855

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK