BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMFLOW V-CEIVER

    MDR report key: 20720077 · Received November 19, 2024

    Report

    Report Number
    3023527320-2024-00002
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 18, 2024
    Manufacturer
    LIMFLOW INC
    Product Code
    MMX
    UDI-DI
    00850041730141
    PMA / PMN Number
    K222083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNSUAL FINDINGS. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THERE HAVE BEEN NO SIMILAR COMPLAINT EVENTS FOR THIS LOT NUMBER. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    A PATIENT WITH CLTI (CHRONIC LIMB-THREATENING ISCHEMIA), CLASSIFIED AS RUTHERFORD CATEGORY 6, UNDERWENT A TADV PROCEDURE (TRANSCATHETER ARTERIALIZATION OF DEEP VEINS) USING THE LIMFLOW DEVICES ON (B)(6) 2024. DURING THE PROCEDURE, THE V-CEIVER WAS INSERTED INTO THE PATIENT'S LATERAL PLANTAR VEIN (LPV) OVER A COMMAND 0.014" GUIDEWIRE. THE GUIDEWIRE HAD TRAVERSED FROM THE POSTERIOR TIBIAL VEIN THROUGH A PERFORATOR AND TO THE PERONEAL VEIN. DUE TO THE TORTUOSITY OF THIS PATIENT'S VENOUS ANATOMY, THE V-CEIVER COULD NOT TRAVERSE THROUGH THE PERONEAL VEIN; THE PHYSICIAN ATTEMPTED TO DELIVER THE V-CEIVER BUT WAS UNSUCCESSFUL. THEY DECIDED TO RETRACT THE V-CEIVER AND SWITCH OUT THE WIRE FOR A STIFFER (V14) GUIDEWIRE HOWEVER THEY WERE STILL NOT ABLE TO DELIVER THE V-CEIVER IN THE PERONEAL VEIN. THE PHYSICIAN STARTED TO RETRACT THE DEVICE WHEN THE TIP BECAME STUCK AND DISCONNECTED FROM THE CATHETER. THE PHYSICIAN MADE AN EFFORT TO RETRIEVE THE DETACHED TIP BY BALLOONING PROXIMAL TO THE TOP IN ATTEMPT TO DRAG THE TIP DOWN INTO THE PEDAL SHEATH WITH NO SUCCESS. GIVEN THE INABILITY TO RETRIEVE THE TIP, THE DECISION WAS MADE TO LEAVE IT IN PLACE. TO PREVENT MIGRATION, A STENT WAS DEPLOYED OVER THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56015 LIMFLOW V-CEIVER DEVICE, PERCUTANEOUS RETRIEVAL MMX LIMFLOW INC VC-US-23 82300261 00850041730141

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention 4FR SHEATH| COMMAND GUIDEWIRE (ABBOTT)| V-14 BOSTON SCIENTIFIC GUIDEWIRE (0.014")