BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3810137 · Received April 30, 2014

    Report

    Report Number
    3008493244-2014-00011
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 3, 2014
    Product Code
    DYB
    PMA / PMN Number
    K132263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT FAILURE ANALYSIS WAS NO POSSIBLE. THE LOT NUMBER WAS NOT REPORTED AND COULD NOT BE DISTINGUISHED FROM MULTIPLE LOTS SHIPPED TO THE FACILITY. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT WAS NOT PERFORMED. THE AXERA 2 ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU), WAS REVIEWED. PSEUDOANEURYSM AND HEMATOMA ARE KNOWN POSSIBLE ADVERSE EFFECTS OF VASCULAR ACCESS PROCEDURES AND ARE LISTED IN THE ADVERSE EFFECTS SECTION OF THE PRODUCT IFU. THE IFU PROVIDES THE APPROPRIATE INSTRUCTIONS ON DEVICE USAGE, WARNING AND PRECAUTIONS; THEREFORE, NO UPDATE IS REQUIRED. BASED ON THE REVIEW COMPLETED, IT IS UNKNOWN WHETHER OR NOT THE DEVICE WAS OUT OF SPECIFICATION AS IT CANNOT BE DEFINITELY DETERMINED. THE ROOT CAUSE, BASED ON AVAILABLE INFORMATION, IS UNKNOWN AS IT CANNOT BE DEFINITELY DETERMINED.

    Description of Event or Problem · 1

    THIS WAS A DIAGNOSTIC CASE. THE PATIENT WAS NOT OBESE AND NO CALCIFICATION, TORTUOSITY, OR SCARRING WERE NOTED. THE INITIAL ACCESS PUNCTURE WAS SATISFACTORY AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. FOLLOWING SHEATH REMOVAL, THE PATIENT'S BLOOD PRESSURE INCREASED TO 210/105 MM/HG. AFTER 5 MINS OF MANUAL COMPRESSION, BLEEDING WAS NOTED AND MORPHINE WAS ADMINISTERED TO REDUCED THE PATIENT'S BLOOD PRESSURE AND CHRONIC PAIN LEVEL. AFTER AN ADDITIONAL 20 MINS OF MANUAL COMPRESSION, HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS MONITORED FOR 30 MINS IN THE RECOVERY ROOM AND SUBSEQUENTLY ADMITTED TO THE CARDIAC UNIT FOR A SURGICAL CONSULT FOR CABG. SIX HOURS LATER, THE PATIENT'S BLOOD PRESSURE BECAME ELEVATED AND SHE STARTED COUGHING. THE ACCESS SITE BEGAN BLEEDING AND MANUAL COMPRESSION WAS APPLIED FOR 30 MINS UNTIL HEMOSTASIS WAS ACHIEVED AGAIN. A SMALL HEMATOMA (GOLF BALL SIZE) WAS OBSERVED. LATER THAT EVENING, THE PATIENT COMPLAINED OF BACK AND GROIN PAIN AT THE ACCESS SITE. THE FOLLOWING DAY, AN ULTRASOUND REVEALED A PSEUDOANEURYSM (4.3 X 2.3 CM), WHICH WAS RESOLVED VIA A FEMOSTOP DEVICE. THE PATIENT REMAINED HOSPITALIZED FOR A CABG. SHE WAS DISCHARGED ON (B)(6) 2014 AND RECOVERED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258659 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization COUMADIN| LOVENOX