MAUDE Adverse Event Report: CORDIS CORPORATION EXOSEAL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	EX600
Medical Device Problem Code	Failure to Fire (2610)
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
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.
Event or Problem Description
As reported, the plug of a 6f exoseal vascular closure device (vcd) was not fully released and the closure was unsuccessful.There was no reported patient injury.Hemostasis was achieved by manual compression.There were no visible signs of device or package damage prior to use, and the device was stored and prepared per instructions for use (ifu).A non-cordis catheter sheath introducer (csi) was used.For the procedure.There were no difficulties connecting the device or advancing it through the non-cordis sheath, and no resistance or sheath deformation was noted.The vascular sheath introducer was retracted until the hub engaged with the indicator wire cowling and was locked with an audible click.Pulsatile flow was observed, and the deployment button was fully depressed with no issue noted with the deployment lever.The device and the non-cordis sheath were removed as a single unit, and upon removal, part of the plug was pulled out and partially fell from the shaft, and the indicator wire was not visible.The femoral artery was verified as suitable with appropriate angle and diameter, with mild plaque, no tortuosity, no nearby stent, and no significant stenosis.There were no pre-existing access site complications noted and no prior closure at the target site.The physician was certified in the use of the device.The procedure was interventional and a retrograde approach was used.The device will be returned for evaluation.

• 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: 25150912
• Report Number: 9616099-2026-00715
• Device Sequence Number: 13448037
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• UDI-Public: (01)10705032058858(17)270731(10)18486841
• 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): 06/24/2026

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: 18486841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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 CATHETER SHEATH INTRODUCER.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 50 KG