MAUDE Adverse Event Report: Cordis US. Corp EXOSEAL; Device, Hemostasis, Vascular

Catalog Number	EX600
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, while using a 6f exoseal vascular closure device (vcd), closure was unsuccessful and hemostasis was not achieved.Pulsatile bleeding was noted 4 minutes after removal of the exoseal vcd and sheath.Hemostasis was achieved by changing to another 6f exoseal.There were no reported injuries to the patient.The device was stored and prepared according to the instructions for use (ifu).The exoseal vascular closure device (vcd) was used for an interventional procedure using a retrograde approach.The physician had achieved certification for use of the exoseal vcd.No visible device or package damage was observed prior to use, and only one exoseal device was used.The arterial site used a 6f non-cordis sheath.Angiography confirmed the femoral artery was suitable for the procedure, including a vascular sheath insertion angle of 30¿45 degrees, and the vessel diameter was confirmed to be at least 5 mm.There was no visible calcium or plaque at the puncture site, no stent near the puncture site, and no stenosis greater than 50% at or near the puncture site.The target femoral site had not been previously closed with a closure device or manual compression within 30 days before the procedure, and there was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site before exoseal vcd use.The deployment button was fully depressed and flush against the handle, and the exoseal vcd and vascular sheath introducer were removed as a single unit approximately 1¿2 seconds after the deployment button was depressed.The indicator wire remained visible upon device removal, the plug was deployed to the proper location, and fingertip compression was maintained on the skin during device removal.No anticoagulants, antiplatelets, or thrombolytics were used.No multiple stick attempts were made before access was achieved.No signs or symptoms of distal blood flow occlusion were observed, and no treatment was provided to restore distal blood flow.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: EXOSEAL
• Common Device Name: Device, Hemostasis, Vascular
• Manufacturer (Section D): Cordis US. Corp; 14201 nw 60 avenue; miami lakes FL
• Manufacturer (Section G): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; +011(786)3138372
• MDR Report Key: 50915221
• Report Number: 9616099-2026-01370
• Device Sequence Number: 5776938
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: EX600
• Device Lot Number: 18500468
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F APT sheath; 6F Exoseal VCD
• Patient Sex: Male