BEUDAMED
    FDA Adverse Event Death Summary report: N

    PINNACLE R/O II INTRODUCER KIT

    MDR report key: 2881457 · Received December 20, 2012

    Report

    Report Number
    1118880-2012-00035
    Event Type
    Death
    Date Received
    December 20, 2012
    Date of Event
    June 20, 2012
    Report Date
    August 2, 2012
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K003424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEATH. PLEASE NOTE THAT THE MAUDE REPORT STATES THAT THIS REPORT WAS NOT A PRODUCT PROBLEM REPORT AND THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THEREFORE, THIS MANUFACTURER MEDWATCH REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE BECAUSE THE SHEATH WAS IDENTIFIED ON THE MAUDE REPORT AS BEING IN USE AT THE TIME OF THE ADVERSE EVENT, ALTHOUGH IT IS UNCLEAR WHAT ROLE, IF ANY, THE SHEATH MAY HAVE PLAYED IN THE EVENT. THE MAUDE EVENT REPORT DID NOT INCLUDE ANY INFORMATION ABOUT THE USER FACILITY, THE REPORTER, OR THE LOT NUMBER INVOLVED. CONSEQUENTLY, THE USER FACILITY COULD NOT BE CONTACTED TO REQUEST ADDITIONAL INFORMATION. IN ADDITION, THE FAILURE INVESTIGATION WAS LIMITED TO THE EVALUATION OF SAMPLES FROM RANDOM LOTS OF THE REPORTED PRODUCT CODE. INSPECTION OF SAMPLES FROM 3 RANDOM LOTS OF THE REPORTED PRODUCT CODE CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS EVENT HAS NOT BEEN REPORTED TO THE MANUFACTURER PREVIOUSLY. THERE IS NO INDICATION THAT THE REPORTED ADVERSE EVENT WAS RELATED TO A DEFECT OR MALFUNCTION OF THE SHEATH. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED IN RELATION TO UF MEDWATCH REPORT # (B)(4), WHICH WAS FOUND ON THE MAUDE DATABASE ON (B)(6) 2012. THE EVENT DESCRIPTION STATES THE FOLLOWING: "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". UNFORTUNATELY, THE MAUDE EVENT REPORT DID NOT INCLUDE ANY INFORMATION ABOUT THE USER FACILITY OR THE REPORTER. THEREFORE, THE USER FACILITY COULD NOT BE CONTACTED TO REQUEST ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE R/O II INTRODUCER KIT CATHETER INTRODUCER DYB TERUMO MEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death HEPARIN: 17400 UNITS