BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMUM HEMOSTASIS INTRODUCER, 4F ACT, 12 CM

    MDR report key: 537466 · Received August 4, 2004

    Report

    Report Number
    2182269-2004-00136
    Event Type
    Injury
    Date Received
    August 4, 2004
    Date of Event
    July 9, 2004
    Report Date
    August 4, 2004
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DIAGNOSTIC HEART CATH PROCEDURE, AFTER ACHIEVING ARTERIAL ACCESS, A 4F ACT SHEATH WAS INSERTED. WHILE ATTEMPTING TO ADVANCE A 5F CORDIS JL4 DIAGNOSTIC CATHETER, THE USER FELT A POP IN THE HUB OF THE SHEATH. THE VALVE HAD NOT RUPTURED AND NO BLEEDING WAS NOTED. THE DIAGNOSTIC CATHETER WAS THEN ADVANCED AND INJECTIONS OF THE LEFT CORONARY SYSTEM WERE COMPLETED WITHOUT DIFFICULTY. UPON REMOVAL OF THE 5F CATHETER, THE HUB OF THE SHEATH FELL ONTO THE DRAPE; A PORTION OF THE SHEATH HAD DETACHED AND A SECTION REMAINED IN THE PT'S ARTERY. ATTEMPTS WERE MADE TO SNARE THE SHEATH WITHOUT SUCCESS AND THE PT WAS TRANSFERRED TO SURGERY TO REMOVE THE DETACHED PORTION. THE PT WAS REPORTEDLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMUM HEMOSTASIS INTRODUCER, 4F ACT, 12 CM ULTIMUM INTRODUCER DYB ST. JUDE MEDICAL, DAIG DIVISION, INC. NA 1061433

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention