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

Model Number	N/A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
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 partially deployed, with half of the plug exposed externally and the other half remaining inside the delivery rod after withdrawal.The plug was removed, and a compression device was used to achieve hemostasis.There was no reported patient injury.The device was used following a lower-limb arteriosclerosis obliterans (aso) procedure.Hemostasis was achieved using a compression device, and the procedure was performed using a retrograde approach in an interventional procedure.The vascular sheath introducer was retracted until the hub engaged with the indicator wire cowling and locked against the handle assembly, with an audible click heard.Pulsatile flow was observed from the bleed-back indicator.The deployment button was fully depressed.The device and sheath were removed as a single unit, and the plug did not fall out of the shaft.The indicator wire was not visible upon removal.A non-cordis catheter sheath introducer was used.Femoral artery suitability was verified on angiography, the vessel diameter was greater than or equal to 5 mm, and there was no calcium, plaque, tortuosity, stent, or stenosis greater than 50% at or near the puncture site.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use.The physician was trained to the device, and the device was stored and prepared according to the instructions for use.The device will be returned for evaluation.

• 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 ; 7863138372
• MDR Report Key: 25270437
• Report Number: 9616099-2026-00792
• Device Sequence Number: 13103781
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• UDI-Public: (01)10705032058858(17)270731(10)18483747
• 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): 06/19/2026

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: 18483747
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2026
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/25/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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 SHEATH INTRODUCER
• Patient Sex: Male
• Patient Weight: 50 KG