BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMOSTOP II

    MDR report key: 3181311 · Received June 14, 2013

    Report

    Report Number
    8030904-2013-00012
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ST JUDE MEDICAL SYSTEMS AB
    Product Code
    DXC
    PMA / PMN Number
    K982182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF OUR INVESTIGATION INDICATED THE EVENT WAS NOT DUE TO THE FEMOSTOP. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT AVAILABLE; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS NOT POSSIBLE. INFORMATION PROVIDED TO SJM STATED THE INITIAL PUNCTURE PERFORMED IN THE COMMON FEMORAL ARTERY WAS A HIGH DOUBLE PUNCTURE, RESULTING IN THE RETROPERITONEAL BLEED. THE PHYSICIAN DID NOT FEEL THE EVENT WAS DUE TO THE FEMOSTOP.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED THAT A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE IN A HIGH DOUBLE PUNCTURE IN THE COMMON FEMORAL ARTERY, FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY AND THE RIGHT CORONARY ARTERY. THE PT WAS HEPARINIZED AND ON ANTICOAGULANTS (UNKNOWN DOSE/STRENGTH/TYPE) FOR THE PROCEDURE. AN ANGIOGRAM REVEALED A RETROPERITONEAL BLEED. THE ANGIO-SEAL DEVICE WAS DEPLOYED, AND THE PT'S BLOOD PRESSURE DROPPED, BUT NO EXTERNAL BLEEDING WAS NOTED. THE PT WAS STABILIZED AND TRANSFERRED TO RECOVERY, WHERE THE BLOOD PRESSURE DROPPED AGAIN. THEN A FEMOSTOP WAS APPLIED, BUT WAS REMOVED AS THE PT REPORTED PAIN. A VASCULAR SURGEON WAS CONSULTED, BUT THE PT EXPIRED DUE TO A RETROPERITONEAL BLEED, BEFORE SURGERY WAS POSSIBLE. THE PHYSICIAN REPORTED THAT THE EVENT WAS NOT DUE TO THE FEMOSTOP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271218 FEMOSTOP II CLAMP, VASCULAR DXC ST JUDE MEDICAL SYSTEMS AB UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death