MAUDE Adverse Event Report: CORDIS US CORP EXOSEAL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	EX600
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
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.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the sponge plug of a 6f exoseal vascular closure device (vcd) could not detach from the device after deployment, resulting in failure to close the right femoral artery.Manual compression and an elastic bandage were used to achieve hemostasis.There was no reported patient injury.The device was used following a coronary interventional procedure for an occlusion of the left circumflex artery (lcx) and the left anterior descending artery (lad).The event was reported to the china national medical products administration (nmpa) as a serious adverse event.Additional information was requested but not provided.The device was not returned as expected.

• 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 ; 7863138372
• MDR Report Key: 25363571
• Report Number: 9616099-2026-00806
• Device Sequence Number: 9892040
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• UDI-Public: (01)10705032058858(17)270131(10)18414712
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: EX600
• Device Lot Number: 18414712
• Was Device Available for Evaluation?: No
• 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: 05/09/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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: 75 YR
• Patient Sex: Male