BEUDAMED
    FDA Adverse Event Death Summary report: N

    PINNACLE

    MDR report key: 2685346 · Received August 7, 2012

    Report

    Report Number
    2685346
    Event Type
    Death
    Date Received
    August 7, 2012
    Date of Event
    June 20, 2012
    Report Date
    August 2, 2012
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A SEVERELY ISCHEMIC RIGHT FOREFOOT WITH TISSUE LOSS DUE TO AN OCCLUDED ANTERIOR TIBIAL ARTERY - WHICH WAS SUCCESSFULLY CROSSED AND ANGIOPLASTIED - RESULTING IN CONTINUOUS FLOW OUT OF HER POPLITEAL THROUGH ANTERIOR TIBIAL TO RIGHT FOOT. AT END OF THE PROCEDURE, STANDARD 6 FRENCH SHEATH WAS PLACED IN LEFT COMMON FEMORAL ARTERY AND SUTURED IN PLACE; THE PT BECAME HYPOTENSIVE AND WAS TRANSFERRED TO ICU; THE PT CODED (B)(6) 2012 AND EXPIRED ON (B)(6) 2012. CAUSE OF DEATH IS SUSPECTED RETROPERITONEAL BLEED FROM THE FEMORAL SHEATH THAT HAD BECOME DISLODGED; PT'S HGB 13.0 ON ADMIT AND DROPPED TO 8.8 ON (B)(6) 2012; WHEN THE GROIN SHEATH WERE ASSESSED, THE SHEATH WAS OUT, THE TIP WAS KINKED. THE PT HAD A VERY LARGE LIPID "APRON".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE HEMOSTATIC SHEATH DYB TERUMO MEDICAL CORP. RSB 60Z *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death HEPARIN: 17400 UNITS DURING PROCEDURE