BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBLIME¿ RADIAL ACCESS GUIDE SHEATH

    MDR report key: 17715808 · Received September 8, 2023

    Report

    Report Number
    3014687026-2023-00006
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 11, 2023
    Report Date
    September 8, 2023
    Manufacturer
    SURMODICS INC
    Product Code
    DYB
    UDI-DI
    05391525785165
    PMA / PMN Number
    K190644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A 6FR GUIDE SHEATH WAS BEING USED FOR LEFT RADIAL ACCESS DURING AN ATHERECTOMY PROCEDURE. A RADIAL DRUG COCKTAIL WAS ADMINISTERED PRIOR TO THE PROCEDURE START, TO RELAX THE TARGET VESSELS. AN ULTRASOUND WAS NOT USED TO VERIFY VESSEL DIAMETER. THE GUIDE SHEATH WAS PLACED IN THE LEFT RADIAL ARTERY TO ACCESS THE LEFT LEG. IT WAS NOTED RESISTANCE WAS ENCOUNTERED DURING GUIDE SHEATH PLACEMENT. AN ORBITAL ATHERECTOMY SYSTEM (OAS) WAS USED IN CONJUNCTION WITH A BALLOON IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THAT "EVERYTHING LOOKED GOOD" UNTIL THAT POINT. DURING DEVICE REMOVAL, THE PATIENT HAD A VESSEL SPASM, AND THE PHYSICIAN WAS UNABLE TO REMOVE THE SHEATH FROM THE PATIENT'S LEFT RADIAL ARTERY. THE PHYSICIAN WAS USING A 0.014" GUIDEWIRE WITHOUT A DILATOR. DURING THE REMOVAL PROCESS, THE SHEATH STRETCHED AND AT ONE POINT THE BRAIDS WERE EXPOSED. FURTHERMORE, THE "SHEATH WAS NO LONGER ON AND IT WAS JUST THE BRAID." AT THAT TIME, THE PHYSICIAN MOVED FURTHER DOWN THE SHEATH WITH HEMOSTATS AND PULLED WITH THE HEMOSTATS APPROXIMATELY 5 CM AT A TIME. THIS MANEUVER WAS REPEATED DOWN THE SHEATH UNTIL IT COULD NOT BE WITHDRAWN ANYMORE. THE PHYSICIAN NOTIFIED A SURGEON, AND THE PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR). A VESSEL CUT DOWN ON THE LEFT RADIAL ARTERY WAS PERFORMED. THE SURGEON WAS UNABLE TO REMOVE THE SHEATH FROM THE CUT DOWN, SO THE SURGEON MOVED TO THE LEFT BRACHIAL ARTERY. A SMALL INCISION WAS MADE AT THE LEFT BRACHIAL ARTERY AND THE SURGEON WAS ABLE TO GRAB THE SHEATH. THE SHEATH WAS THEN CUT SO THE SURGEON COULD REMOVE THE REMAINING SHEATH IN THE DESCENDING AORTA (PHYSICIAN WANTED TO REMOVE THE SHEATH FROM THE BIGGER VESSEL FIRST). ONCE THE SHEATH WAS REMOVED AND THE INCISIONS WERE CLOSED, THE PATIENT HAD PALPABLE PULSES. THERE WAS NO FURTHER IMPACT TO THE PATIENT. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY 30 - 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179255 SUBLIME¿ RADIAL ACCESS GUIDE SHEATH Introducer, catheter DYB SURMODICS INC SRA-GS35-6F120 22201208 05391525785165

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention