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

Catalog Number	EX700
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the deployment button of a 7f exoseal vascular closure device (vcd) could not be pressed, and the plug could not be released.After removal from the patient, the plug had not detached from the exoseal vcd.Manual compression was used for hemostasis.There was no reported patient injury.A retrograde approach was used.There were no visible signs of device or package damage before use.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.No stent was present near the puncture site.No resistance, excessive force, or difficulty connecting the vcd to the vascular sheath introducer was reported.The sheath introducer was retracted until its hub engaged with the indicator wire cowling, locked against the handle assembly, and an audible click was heard.Agiography confirmed the suitability of the femoral artery and that the insertion angle of the vascular sheath introducer was 30¿45 degrees.The vessel diameter was confirmed to be greater than or equal to 5mm, with no obvious calcium deposition, plaque, stent, or stenosis greater than 50% observed at or near the puncture site.Pulsatile flow was observed from the bleed-back indicator, and the vcd and sheath introducer were retracted together until the indicator window turned solid black.The deployment button was not fully depressed and flush with the handle; whether excessive force was required to fully depress the button was not verified.Before use of the exoseal vcd, there was no evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site.The device will be returned for evaluation.
Additional Manufacturer Narrative
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: 50842663
• Report Number: 9616099-2026-01319
• Device Sequence Number: 18707856
• Product Code: MGB
• UDI-Device Identifier: 10705032058896
• UDI-Public: (01)10705032058896(17)270930(10)18519273
• 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): 09/21/2026

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: EX700
• Device Lot Number: 18519273
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2025
• 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: unknown vascular sheath introducer
• Patient Sex: Male