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

Catalog Number	EX600
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the plug deployment button of a 6f exoseal vascular closure device (vcd) could not be pressed after the indicator window changed from black- white to black- black.The device was withdrawn, and manual compression was used to achieve hemostasis.There was no reported patient injury.No abnormality was noted prior to use.The indicator wire loop deployed smoothly.The sheath and closure device were withdrawn together at an angle of 30¿45°.Pulsatile blood flow was observed from the bleed-back port and slowed significantly prior to further withdrawal.The device was inspected after removal.Pulling the indicator wire loop caused the indicator window to change color.Pressing the plug deployment button outside the body could not be performed easily.The procedure performed was intracranial aneurysm embolization.The device will be returned for evaluation.

• Brand Name: EXOSEAL
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 25138048
• Report Number: 9616099-2026-00709
• Device Sequence Number: 9453881
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• UDI-Public: (01)10705032058858(17)270731(10)18486893
• 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): 05/21/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: EX600
• Device Lot Number: 18486893
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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: TEMPO 5F MPA1 CATHETER.; UNK WOBBI CATHETER, UNK STRYKER .014 GUIDEWIRE.; UNK TONGQIAOFENG EMBOLIZATION COIL.
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian