BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMUM HEMOSTATSIS INTRODUCER, 5F, 12CM SHEATH

    MDR report key: 621668 · Received July 19, 2005

    Report

    Report Number
    2182269-2005-00135
    Event Type
    Injury
    Date Received
    July 19, 2005
    Date of Event
    June 21, 2005
    Report Date
    July 19, 2005
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A DIAGNOSTIC ANGIOGRAM. FOLLOWING PREPARATION OF THE GROIN AND INFILTRATION WITH LOCAL ANESTHESIA, THE 5F ULIMUM INTRODUCER SHEATH WAS USED TO ACCESS THE RIGHT FEMORAL ARTERY. WHEN THE PHYSICIAN REMOVED THE DILATOR AND WIRE FROM THE PATIENT IT WAS NOTED THE SHEATH HAD SEPARATED FROM THE HUB; MANUAL COMPRESSION WAS APPLIED. X-RAY SHOWED THE DISCONNECTED SECTION; THE PHYSICIAN GOT THE IMPRESSION THAT, DUE TO A KINK ON THE PLASTIC TUBE, A PART OF ABOUT 1.5 CM STILL REMAINED OUTSIDE THE VESSEL. THE PATIENT UNDERWENT SURGERY TO REMOVE THE RETAINED SECTION FOLLOWED BY INSERTION OF COLLAGEN HEMOSTATIC SYSTEM AND LOCAL APPLICATION OF D-STAT-FLOWABLE-HAEMOSTAT. WHEN THE WOUND WAS DRY, THE CUTANEOUS TISSUE WAS SUTURED, A COMPRESSION DRESSING WAS APPLIED AND THE PATIENT WAS TRANSFERRED TO THE ICU FOR FURTHER OBSERVATION. THE PATIENT WAS STABLE DURING THE PROCEDURE WITH PALPABLE PULSES. AFTER THE MOBILIZATION OF THE PATIENT (DATE AND TIME UNKNOWN), THE PATIENT DEVELOPED A PULMONARY EMBOLISM AND HAD TO BE RESUSCITATED. SUBSEQUENT MULTI-ORGAN FAILURE REQUIRED INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMUM HEMOSTATSIS INTRODUCER, 5F, 12CM SHEATH ULTIMUM HERMOSTASIS INTRO DYB ST. JUDE MEDICAL NA 1131575

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention