BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST CATH HEMOSTASIS INTRODUCER, 7.5F, 12CM

    MDR report key: 1895408 · Received November 4, 2010

    Report

    Report Number
    2182269-2010-00201
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K914090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 7.5 F 12 CM FAST CATH HEMOSTASIS INTRODUCER SHEATH WAS USED DURING AN EP STUDY IN THE RIGHT FEMORAL VEIN PUNCTURE SITE. TWO OTHER INTRODUCER SHEATHS SHARED THIS SAME PUNCTURE SITE. A 6F CATHETER HAD BEEN INSERTED THROUGH THE INTRODUCER SHEATH. UPON COMPLETION OF THE EP STUDY THE CATHETER WAS REMOVED FROM THE SHEATH. WHEN REMOVING THE SHEATH, THERE WAS RESISTANCE. THE HEMOSTASIS VALVE HAD SEPARATED FROM THE SHAFT OF THE SHEATH WHICH REMAINED IN THE VEIN. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE THIS PORTION OF THE SHEATH VIA A VENOUS CUT DOWN WHERE THEY WERE ABLE TO SNARE THE SHEATH. MANUAL COMPRESSION WAS APPLIED FOR 45 MINUTES AND THE PATIENT DEVELOPED ECCHYMOSIS AT THE RIGHT FEMORAL VEIN PUNCTURE SITE. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. THE PATIENT WAS NOT TAKING ANY ANTI-COAGULANT MEDICATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST CATH HEMOSTASIS INTRODUCER, 7.5F, 12CM FAST-CATH INT, 7.5F DYB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R LISINOPRIL| ATENOLOL| GLIPIZIDE| SYNTHROID| ACTOS| THE PATIENT WAS TAKING MEDICATIONS OF NEURONTIN