BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

    MDR report key: 17438256 · Received August 1, 2023

    Report

    Report Number
    3013479847-2023-00005
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    March 11, 2022
    Report Date
    July 31, 2023
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    PMA / PMN Number
    K192873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, THE LOT NUMBER WAS NOT REPORTED AND THEREFORE A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. HEMATOMA IS KNOWN COMPLICATION FOR CTR SURGICAL PROCEDURES. THE ULTRAGULDECTR INSTRUCTIONS FOR USE OUTLINE THAT "CARPAL TUNNEL RELEASE USING ULTRAGULDECTR REPRESENTS A SURGICAL PROCEDURE. OPERATORS AND STAFF SHOULD FOLLOW APPROPRIATE PRECAUTIONS AND PROCEDURES".

    Description of Event or Problem · 0

    THE PHYSICIAN PERFORMED A CARPAL TUNNEL RELEASE USING ULTRASOUND GUIDANCE, AFTER WHICH THE PATIENT DEVELOPED A CARPAL TUNNEL HEMATOMA. THE PATIENT WAS CHRONICALLY TAKING AN ANTICOAGULANT, COUMADIN (NO MECHANICAL HEART VALVE(S)). THE PHYSICIAN'S STANDARD PRACTICE IS TO STOP ANTICOAGULANTS, TYPICALLY 3 DAYS BEFORE THE PROCEDURE. THE PATIENT FOLLOWED THE INSTRUCTIONS GIVEN AND DISCONTINUED COUMADIN A FEW DAYS PRIOR TO THE PROCEDURE. THE PROCEDURE WAS UNEVENTFULLY CARRIED OUT AND THE PATIENT WAS DISCHARGED. THE SAME AFTERNOON OF THE PROCEDURE THE PATIENT RETURNED TO THE COUMADIN CLINIC AND WAS INADVERTENTLY ADMINISTERED LOVENOX TO BRIDGE THE PATIENT WHILE RESTARTING COUMADIN. THE PATIENT THEN RETURNED TO SEE THE PHYSICIAN THE FOLLOWING MONDAY (3 DAYS POST-OP) AND WAS SHOWING SIGNS OF SWELLING AND DISCOMFORT IN THE HAND. THE PHYSICIAN ENSURED THERE WAS NO PRESENCE OF INFECTION OR INJURY AND SUSPECTED A CARPAL TUNNEL HEMATOMA AND THUS PROCEEDED WITH AN INCISION AND DRAINAGE PROCEDURE IN THE OPERATING ROOM, WHICH RESOLVED THE ISSUES. THE PHYSICIAN BELIEVES THE HEMATOMA WAS CAUSED BY IMMEDIATE POST-PROCEDURAL BRIDGING WITH LOVENOX VERSUS JUST RESTARTING COUMADIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555386 ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE) CARPAL TUNNEL RELEASE SYSTEM LXH SONEX HEALTH 600112-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention