BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOSEAL CS-23-VSD

    MDR report key: 1173487 · Received September 22, 2008

    Report

    Report Number
    1222632-2008-00010
    Event Type
    Other
    Date Received
    September 22, 2008
    Date of Event
    July 15, 2008
    Report Date
    September 18, 2008
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    PMA / PMN Number
    P000049
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT HISTORY RECORD REVIEWED. ADDITIONAL INFORMATION REQUESTED FROM INITIAL REPORTER (B) (6) (B) (4).

    Description of Event or Problem · 1

    TIP OF CARDIO SEAL DEVICE BROKE OFF FROM THE TIP OF THE DELIVERY DEVICE AND WAS WEDGED IN THE RFV/SUBCUTANEOUS TISSUE AND NEEDED TO BE REMOVED IN THE OR ADDITIONAL INFORMATION PROVIDED BY (B) (6) HOSPITAL IN A LETTER DATED 2008: A SIZING BALLOON WAS PLACED AND INFLATED FOR MEASUREMENT. THE OCCLUDER DEVICE WAS NOT LARGE ENOUGH, WAS RECAPTURED AND REMOVED FOR A LARGER DEVICE. THE OCCLUDER DEVICE WOULD NOT PULL BACK THROUGH THE SHEATH. THE ENTIRE UNIT (DELIVERY SHEATH AND SHEATH) PULLED BACK AS ONE, BUT THE TIP OF THE OCCLUDER DEVICE SNAPPED OFF FROM THE TIP AND THE TIP REMAINED IN THE RFV. VASCULAR SURGERY WAS CONSULTED AND THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR REMOVAL OF THE TIP OF THE CARDIO SEAL DEVICE. THERE WERE NO FURTHER SIDE EFFECTS OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-23-VSD MLV NMT MEDICAL, INC. CS-23-VSD 0704030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DELIVERY DEVICE (NOT SPECIFIED)