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

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the deployment button of a 6f exoseal vascular closure device (vcd) could not be pressed.The button depressed only partially and was not able to be fully depressed.Hemostasis was achieved using a suture device.There was no reported patient injury.The exoseal vascular closure device (vcd) and vascular sheath introducer were retracted together until pulsatile flow significantly slowed or stopped from the bleed-back indicator and until the indicator window changed to solid black.The indicator window was solid black at that time and did not show red during retraction.The device was not attempted to be deployed outside the patient's body.A non-cordis 6f short sheath was used.The device was used for an interventional procedure and an antegrade approach was used.Femoral artery suitability, including the vascular sheath introducer insertion angle of 30-45 degrees, was verified by angiography, and the vessel diameter was verified to be at least 5 mm.There was no visible calcium or plaque, access vessel tortuosity, stent near the puncture site, or greater than 50% stenosis at or near the puncture site.The target femoral site had not been previously closed with a closure device or manual compression within 30 days before the procedure.There was no evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site before exoseal vcd use.The patient's body mass index was not greater than 40.The physician had achieved certification for use of the exoseal vcd.The device was stored and prepared according to the instructions for use (ifu).There were no visible signs of device or package damage prior to use.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: 50776626
• Report Number: 9616099-2026-01278
• Device Sequence Number: 10754754
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• 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 Model Number: N/A
• Device Catalogue Number: EX600
• Device Lot Number: 18494567
• 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
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2025
• 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: Terumo 6F short sheath.
• Patient Sex: Male
• Patient Weight: 149 LB