BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA MEDICAL INC. VASCADE MVP VCS

    MDR report key: 24784024 · Received April 3, 2026

    Report

    Report Number
    3011469355-2026-00016
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 29, 2026
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF THE INVESTIGATION, STAFF CONSULTED WITH THE PHYSICIAN, WHO PROVIDED THEIR ASSESSMENT AND COMPARISON WITH SIMILAR RECENT CASES. THE PHYSICIAN REPORTED THAT THIS ISSUE HAS OCCURRED IN THREE CONSECUTIVE PROCEDURES INVOLVING THE USE OF A 6 FR SHORT SHEATH. NOTABLY, ALL AFFECTED PATIENTS WERE FEMALE. THE PHYSICIAN SUGGESTED THAT PATIENT STRAINING DUE TO PAIN DURING DEVICE REMOVAL AND HEMOSTASIS PARTICULARLY IN PSVT PROCEDURES PERFORMED UNDER LIGHT SEDATION MAY HAVE CONTRIBUTED TO THE DIFFICULTY. IN CONTRAST, A 6 FR SHORT SHEATH WAS ALSO USED IN A SEPARATE PVC CASE INVOLVING A MALE PATIENT. ALTHOUGH SOME RESISTANCE WAS ENCOUNTERED DURING VASCADE REMOVAL, THE DEVICE WAS SUCCESSFULLY REMOVED WITH MODERATE FORCE. REGARDING COLLAGEN HYDRATION TIME, THE PHYSICIAN NOTED THAT IN ONE INSTANCE THE SECOND VASCADE DEVICE DEPLOYED USING THE CLIP METHOD ALSO DID NOT RELEASE EASILY. BASED ON THIS OBSERVATION, COLLAGEN HYDRATION TIME IS NOT CONSIDERED A CONTRIBUTING FACTOR TO THE ISSUE. THE VASCADE MVP WAS RETURNED AND THE EVALUATION IS ONGOING THEREFORE UPON COMPLETION A SUPPLEMENT REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR THE TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT). HEMOSTASIS WAS ACHIEVED USING TWO VASCADE MVP CLOSURE DEVICES DEPLOYED THROUGH 6 FR SHORT SHEATHS AND ONE SL0 SHEATH. USING THE CLIP METHOD, HEMOSTASIS WAS PERFORMED FROM THE DISTAL (FOOT) SIDE IN THE FOLLOWING SEQUENCE: SL0 SHEATH (WHICH HAD REPLACED A 7 FR SHORT SHEATH), FOLLOWED BY THE TWO 6 FR SHORT SHEATHS. THE COLLAGEN PLUG OF THE THIRD VASCADE DEVICE WAS DEPLOYED, AND AFTER A 40-SECOND COUNT, ALL DEVICES WERE WITHDRAWN. THE VASCADE DEVICE AT THE SL0 PUNCTURE SITE WAS REMOVED WITHOUT DIFFICULTY. HOWEVER, THE TWO DEVICES ASSOCIATED WITH THE 6 FR SHORT SHEATHS BECAME LODGED IN THE SUBCUTANEOUS TISSUE AND COULD NOT BE REMOVED USING STANDARD TECHNIQUE. THE PHYSICIAN ULTIMATELY REMOVED THE DEVICES BY MAKING SMALL INCISIONS AT THE PUNCTURE SITES WITH A SCALPEL. HEMOSTASIS WAS NOT IMMEDIATELY ACHIEVED AND REQUIRED MANUAL COMPRESSION FOR MORE THAN 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100975 CARDIVA MEDICAL INC. VASCADE MVP VCS VASCADE MVP MGB CARDIVA MEDICAL, INC. 800-612C-05J G612C251002A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention