MAUDE Adverse Event Report: CORDIS CORPORATION 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	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when operating a 6f exoseal vascular closure device (vcd) the marker did not change, so it was retrieved.There was no reported patient injury.Additional information was requested but not provided.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.A review of the manufacturing documentation associated with lot 18404937 presented no issues during the manufacturing process that can be related to the reported event.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 CORPORATION; 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: 25285089
• Report Number: 9616099-2026-00795
• Device Sequence Number: 15844877
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• UDI-Public: (01)10705032058858(17)261231(10)18404937
• 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): 06/18/2026

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: 18404937
• 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: 05/01/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian