MAUDE Adverse Event Report: CARDIVA MEDICAL, INC. CARDIVA MEDICAL INC. VASCADE MVP VCS

Model Number	800-612C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a peripheral watchman procedure in which the vascade mvp was deployed through a 9f access sheath to achieve hemostasis.Initial hemostasis was achieved; however, bleeding occurred upon ambulation after three hours of bed rest.The physician reported that manual compression was applied, after which the patient was placed on an additional six hours of bed rest and admitted for overnight monitoring.This is report 2 of 2.
Additional Manufacturer Narrative
The vascade mvp devices will not be returned for evaluation, as the user facility has discarded them.The user facility reported that the disc was inspected prior to use no anomalies were reported.The cause of the reported event cannot be determined.The vascade mvp® venous vascular closure system (vvcs) instructions for use model 800-612c 6-12f (venous) states that bleeding from the puncture site is a complication that may occur and may be related to the procedure or the vascular closure.This report is submitted for patient 2.A separate mdr has been filed for patient 1; please reference mfr.3011469355-2026-00018.

• Brand Name: CARDIVA MEDICAL INC. VASCADE MVP VCS
• Common Device Name: VASCADE MVP
• Manufacturer (Section D): CARDIVA MEDICAL, INC.; 1615 wyatt drive; santa clara CA 95054
• Manufacturer (Section G): CARDIVA MEDICAL, INC.; carretera internacional km. 12; 129, salida norte de guayma; guaymas sonora, 85340 ; MX 85340
• Manufacturer Contact: erina marshall ; 1615 wyatt drive; santa clara, CA 95054
• MDR Report Key: 24742957
• Report Number: 3011469355-2026-00019
• Device Sequence Number: 8695101
• Product Code: MGB
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P120016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 800-612C
• Device Lot Number: G612C250721C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown