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

Catalog Number	EX500
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the indicator windows of a 5f exoseal vascular closure device (vcd) did not change color, and the plug did not deploy.Manual compression with gauze was used to achieve hemostasis.There was no reported patient injury.The device was stored and prepared according to the instructions for use.There was no difficulty connecting the 6f 2.0mm × 0.97mm.038-inch 11cm avanti+ sheath introducer to the exoseal vcd.The indicator wire cowling locked against the handle assembly, and an audible click was heard.Pulsatile flow was observed from the bleed-back indicator.The exoseal vcd and sheath introducer were retracted together until bleed back significantly slowed or stopped.The indicator did not display black-black, and the indicator window did not show red during retraction.The physician did not have their thumb on the plug deployment button during retraction.Femoral artery suitability was verified by angiography, including an insertion angle of 30-45 degrees, and the vessel diameter was verified to be at least 5 mm.There was no visible calcium or plaque, no access vessel tortuosity, 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 closed with a closure device or manual compression less than 30 days before the procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site before exoseal vcd use.The exoseal vcd was used in a diagnostic procedure, the procedure used an antegrade approach, and the physician had achieved certification on the use of 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: 50783123
• Report Number: 9616099-2026-01290
• Device Sequence Number: 10529560
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: EX500
• Device Lot Number: 18582145
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2026
• 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 11cm Avanti+ sheath introducer
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 149 LB