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

Catalog Number	EX500
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the deployment button of a 5f exoseal vascular closure device (vcd) could not be pressed, and the device could not be deployed.Manual compression was used for hemostasis.There was no reported patient injury.The procedure used a retrograde approach, and the physician was certified in the use of the exoseal vcd.There were no visible signs of device or package damage before use.The device was stored and prepared according to the instructions for use (ifu).One exoseal vcd and an unknown catheter sheath introducer were used for the patient.Angiography confirmed the suitability of the femoral artery and that the insertion angle of the vascular sheath introducer was 30¿45 degrees.The vessel diameter was confirmed to be greater than or equal to 5mm, and no obvious calcium deposition, plaque, stent, or stenosis greater than 50% was observed at or near the puncture site.Before use of the exoseal vcd, there was no evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site.The exoseal vcd and vascular sheath introducer were retracted together until pulsatile flow from the bleed-back indicator significantly slowed or stopped and until the indicator window changed to solid black.When deployment was attempted, the button would not depress at all.The indicator window was solid black at that time and did not display any red color during retraction.The device was not attempted to be deployed outside the patient¿s body.There was no access vessel tortuosity.The target femoral site had not been closed with a closure device or manual compression less than 30 days before the procedure.The exoseal vcd was used in an interventional procedure.After removal from the patient, the plug had not detached from the exoseal vcd.The device will be returned for evaluation.
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.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 33014
• 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: 50783109
• Report Number: 9616099-2026-01294
• Device Sequence Number: 10516079
• Product Code: MGB
• UDI-Device Identifier: 10705032058872
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: EX500
• Device Lot Number: 18483666
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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: unknown vascular sheath introducer
• Patient Sex: Unknown
• Patient Race: Asian