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	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the button of a 5f exoseal vascular closure device (vcd) could not be pressed during a carotid artery stent implantation procedure.The deployment button was reported as fully depressed and flush with the handle; however, it was also reported that excessive force was required and that the button only depressed halfway.Hemostasis was ultimately achieved using a suture-mediated closure device.There was no reported patient injury.The exoseal vascular closure device (vcd) was stored, inspected, handled, and prepared according to the instructions for use (ifu), with no abnormalities noted prior to use.An antegrade approach was used, and femoral artery suitability was verified by angiography, including an appropriate insertion angle and a vessel diameter of at least 5 mm.No visible calcium/plaque, stent, or stenosis greater than 50% was reported at or near the puncture site.No resistance, excessive force, or difficulty connecting the vcd to the sheath introducer was reported.The sheath introducer engaged and locked with the handle assembly, an audible click was heard, and pulsatile flow was observed.The indicator window turned solid black.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.

• 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: 50773886
• Report Number: 9616099-2026-01276
• Device Sequence Number: 10529007
• 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): 09/15/2026

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: EX500
• Device Lot Number: 18510901
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 10/03/2025
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 127 LB