BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA MEDICAL INC. VASCADE MVP XL VVCS

    MDR report key: 23593095 · Received November 19, 2025

    Report

    Report Number
    3011469355-2025-00050
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 19, 2025
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED BY THE USER FACILITY. THIS EVENT WAS REVIEWED BY HAEMONETICS MEDICAL STAFF, WHO DETERMINED THAT THE VASCADE DEVICE FUNCTIONED AS INTENDED, WITH NO EVIDENCE OF MALFUNCTION OR MATERIAL DEFECT. THE PATIENT'S RETROPERITONEAL HEMATOMA REQUIRING TRANSFUSION AND HOSPITALIZATION IS MOST LIKELY ATTRIBUTABLE TO MULTIFACTORIAL PROCEDURAL OR TECHNIQUE-RELATED FACTORS (E.G., PARTIAL PULL-THROUGH, POSSIBLE BACK-WALL PUNCTURE). IT CANNOT BE EXCLUDED THAT DEVICE USE CONTRIBUTED INDIRECTLY TO THE EVENT. EVEN THOUGH NO MALFUNCTION OCCURRED, THE USE OF THE VASCADE IS TEMPORALLY AND PROCEDURALLY LINKED TO THE ADVERSE EVENT, AND THE ROOT CAUSE MAY INCLUDE DEVICE-PROCEDURE INTERACTION.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN INTERVENTIONAL PULSED FIELD ABLATION PROCEDURE USING VASCADE MVP PLACED THROUGH A 16.8 F OD PFA SHEATH, LATER DOWNSIZED TO AN 8 F SHEATH FOR ACCESS AND DILATION. CLOSURE INVOLVED ONE ACCESS SITE IN THE RIGHT GROIN WITH AN MVP XL AND TWO IN THE LEFT GROIN WITH MVP DEVICES; BOTH MVP DEPLOYMENTS WERE UNEVENTFUL. DURING MVP XL DEPLOYMENT, A PARTIAL PULL-THROUGH OCCURRED WHEN THE PHYSICIAN REMOVED THE SHEATH AND ATTEMPTED TO CONFIRM TEMPORARY HEMOSTASIS. A "POP" WAS NOTED, AND APPROXIMATELY HALF OF THE BLACK SLEEVE BENEATH THE WHITE MARKER STRIPE BECAME VISIBLE, THOUGH THE DISC DID NOT EXIT THE SKIN. THE PHYSICIAN PROCEEDED WITH COLLAGEN DEPLOYMENT, ADVANCING THE DISC SLIGHTLY, DEPLOYING THE COLLAGEN, AND TAMPING IT BENEATH THE SKIN. MINIMAL BACK-BLEEDING WAS OBSERVED, AND ONLY SLIGHT OOZING WAS PRESENT AFTER DEVICE REMOVAL. IT IS UNCLEAR WHETHER MANUAL PRESSURE WAS HELD FOR THE RECOMMENDED DURATION. THE PATIENT REMAINED STABLE FOR 45 MINUTES BEFORE DEVELOPING HYPOTENSION (SBP 70 MMHG), WHICH RESOLVED WITH A FLUID BOLUS. MILD TRACT OOZING OCCURRED AND THE DRESSING WAS CHANGED. AFTER AN ADDITIONAL 1.5 HOURS OF BED REST, THE PATIENT BECAME HYPOTENSIVE AGAIN WHILE ATTEMPTING TO AMBULATE AND REPORTED ABDOMINAL PAIN AND URINARY URGENCY. CT IMAGING REVEALED RETRO-PELVIC BLEEDING WITH A HEMATOMA EXTENDING TO THE RIGHT LOWER QUADRANT AND FREE AIR ON THE LEFT SIDE DISPLACING THE BLADDER. A FOLEY CATHETER RELIEVED BLADDER PRESSURE, AND THE PATIENT RECEIVED TWO UNITS OF BLOOD. ASIDE FROM THE INITIAL TRACT OOZING, NO EXTERNAL BLEEDING WAS OBSERVED. THE PATIENT REMAINED HOSPITALIZED FOR OBSERVATION AND WAS REPORTED TO BE DOING WELL AFTER TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297524 CARDIVA MEDICAL INC. VASCADE MVP XL VVCS VASCADE MVP XL MGB CARDIVA MEDICAL, INC. 800-1012XL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R