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	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, part of the plug of a 5f exoseal vascular closure device (vcd) was pulled out and bleeding was observed at the puncture site when the device was removed.Manual compression was used to achieve hemostasis.There was no reported patient injury.There was no difficulty connecting the vascular sheath introducer with the exoseal vascular closure device (vcd), no resistance or friction was experienced while advancing the exoseal vcd through the sheath, and the sheath was not kinked or bent.The vascular sheath introducer was retracted until the hub engaged with the indicator wire cowling and locked against the handle assembly.An audible click was heard, pulsatile flow was observed from the bleed-back indicator, and the deployment button was fully depressed and flush against the handle.There was no issue with or damage to the deployment lever.The exoseal vcd and vascular sheath introducer were removed as a single unit approximately 1¿2 seconds after depressing the deployment button, and the plug was brought out when the device was removed.The indicator wire was not visible when the device was removed.A non-cordis catheter sheath introducer was used.Femoral artery suitability was verified on angiography, including the vascular sheath introducer insertion angle, and the vessel diameter was verified to be at least 5 mm.There was no visible calcium or plaque at the puncture site.There was no stent near the puncture site.There was no stenosis greater than 50% 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 exoseal vcd was used in a diagnostic procedure using a retrograde approach.The patient¿s body mass index was not greater than 40.There were no visible signs of device/package damage prior to use.The physician had achieved certification for use of the exoseal vcd.The device was stored and prepared according to the instructions for use (ifu).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: 50773742
• Report Number: 9616099-2026-01274
• Device Sequence Number: 9488473
• Product Code: MGB
• UDI-Device Identifier: 10705032058872
• 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: Other,Foreign,Health Professional
• 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: EX500
• Device Lot Number: 18528990
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 101 LB