BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA MEDICAL INC. VASCADE MVP VVCS

    MDR report key: 24752187 · Received April 1, 2026

    Report

    Report Number
    3011469355-2026-00017
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 1, 2026
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VASCADE MVP DEVICES WILL NOT BE RETURNED TO HAEMONETICS FOR EVALUATION. IT WAS REPORTED THAT THE DEVICE WAS OPENED AND CLOSED CORRECTLY, COLLAGEN DEPLOYMENT WAS SUCCESSFUL, AND TEMPORARY HEMOSTASIS WAS ACHIEVED. AS PART OF THE INVESTIGATION, HAEMONETICS SPOKE WITH THE PERFORMING PHYSICIAN, WHO INDICATED THEY ARE USING A BOSTON PFA SYSTEM FARAPULSE WITH A 16.5 FR OD SHEATH AND DOWNSIZING AFTER THE PROCEDURE. THIS CONSTITUTES OFF-LABEL USE, AS THE INSTRUCTIONS FOR USE (IFU) SPECIFY A MAXIMUM SHEATH SIZE OF 15 FR OD. HAEMONETICS PERSONNEL INFORMED THE CUSTOMER THAT THE USE OF A 16.5 FR OD SHEATH IS OFF-LABEL AND NOT RECOMMENDED. ADDITIONALLY, A HAEMONETICS CLINICAL SPECIALIST, IN COLLABORATION WITH THE DISTRIBUTOR PARTNER, WILL VISIT THE FACILITY TO MEET WITH THE CUSTOMER ON-SITE AND OBSERVE PROCEDURES. THIS ASSESSMENT WILL INCLUDE A REVIEW OF THE AFTERCARE PROCESS AND AN EVALUATION OF ANY RECENT CHANGES, SUCH AS STAFF TURNOVER OR DEVICE STORAGE PRACTICES. THE VASCADE MVP® VENOUS VASCULAR CLOSURE SYSTEM (VVCS) INSTRUCTIONS FOR USE MODEL 800-612C 6-12F (VENOUS) REBLEED AND HEMATOMA COMPLICATIONS MAY OCCUR AND MAY BE RELATED TO THE PROCEDURE OR THE VASCULAR CLOSURE.

    Description of Event or Problem · 0

    A DISTRIBUTOR NOTIFIED HAEMONETICS THAT A CUSTOMER (B)(6) REPORTED APPROXIMATELY 15 PATIENTS WHO UNDERWENT INTERVENTIONAL CORONARY PROCEDURES IN WHICH THE VASCADE MVP DEVICE (LOT#: G612C251021A OR LOT#: G612C250430B) WAS DEPLOYED THROUGH A 15 FR SHEATH FOR VASCULAR CLOSURE. IT WAS FURTHER INDICATED THAT A BOSTON SCIENTIFIC FARAPULSE PFA SYSTEM, UTILIZING A 16.5 FR OUTER DIAMETER SHEATH, WAS USED DURING THE PROCEDURES, WITH SUBSEQUENT DOWNSIZING PRIOR TO CLOSURE. THIS REPRESENTS OFF-LABEL USE, AS THE INSTRUCTIONS FOR USE (IFU) SPECIFY A MAXIMUM SHEATH SIZE OF 15 FR OD. THE PHYSICIAN REPORTED THAT HEPARIN WAS USED AS THE ANTICOAGULANT DURING THE PROCEDURES. TEMPORARY HEMOSTASIS WAS ACHIEVED AT THE CONCLUSION OF EACH CASE. POST-PROCEDURE, VENOUS BLEEDING WAS OBSERVED IN ALL REPORTED CASES. EACH PATIENT REQUIRED ADDITIONAL INTERVENTION, INCLUDING ONE OF THE FOLLOWING: USE OF A FEMOSTOP DEVICE, APPLICATION OF A COMPRESSION BANDAGE FOR TWO OR MORE HOURS, OR EXTENDED HOSPITALIZATION. THE PHYSICIAN REPORTED THAT NONE OF THE PATIENTS WERE CONSIDERED TO BE VITALLY THREATENED. IN ONE CASE, A PATIENT WAS DISCHARGED FOLLOWING CONFIRMED HEMOSTASIS BUT LATER RETURNED THE SAME DAY WITH A SEVERE GROIN HEMATOMA. THE PATIENT'S COURSE OF TREATMENT IS UNKNOWN. HAEMONETICS FOLLOWED UP WITH THE USER FACILITY TO CLARIFY HOW MANY PATIENTS REQUIRED HOSPITALIZATION AND TO OBTAIN ADDITIONAL DETAILS REGARDING TREATMENT OF THE PATIENT WHO EXPERIENCED THE SEVERE GROIN HEMATOMA. THE USER FACILITY DECLINED TO PROVIDE FURTHER INFORMATION. THE USE OF MANUAL COMPRESSION METHODS, INCLUDING FEMSTOP AND COMPRESSION BANDAGES, IS NOT CONSIDERED A MEDICAL INTERVENTION. HAEMONETICS WILL SUBMIT TWO REPORTS FOR HOSPITALIZATION AND TWO REPORTS FOR SEVERE GROIN HEMATOMA, WITH ONE REPORT CORRESPONDING TO EACH SUBJECT DEVICE AND ASSOCIATED PATIENT OUTCOME. THIS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545768 CARDIVA MEDICAL INC. VASCADE MVP VVCS VASCADE MVP VVCS MGB CARDIVA MEDICAL, INC. 800-612C-05E G612C250430B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization