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

Catalog Number	EX500
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the indicator window of a 5f exoseal vascular closure device (vcd) could not change to black-black, so the device was withdrawn directly from the body.Hemostasis was achieved with manual compression.There was no reported patient injury.The operator used the device to close the puncture site.There were no visible signs of device or package damage prior to use.The device was stored and prepared according to the instructions for use (ifu).There was no difficulty connecting the vascular sheath introducer with the exoseal vcd.The indicator wire cowling locked against the handle assembly, and an audible click was heard.Pulsatile flow was observed from the bleed-back indicator.The exoseal vcd and vascular sheath introducer were retracted together until bleed-back significantly slowed or stopped.The physician did not have their thumb on the plug deployment button during retraction.The indicator window did not show red during retraction.When the device was removed from the patient, the indicator wire loop was deployed/showing, and no anomalies were noted to the loop.Outside the patient's body, the guidewire loop required considerable force to make the indicator window turn black-black.A non-cordis catheter sheath introducer was used.Angiography confirmed suitability of the femoral artery, including the vascular sheath introducer insertion angle.The vessel diameter was confirmed to be greater than or equal to 5 mm.There was no visible calcium/plaque at the puncture site and no access vessel tortuosity.There was no stent near the puncture site, and there was no vessel 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 pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to exoseal vcd use.The exoseal vcd was used in a diagnostic procedure with a retrograde approach.The patient's body mass index (bmi) was not greater than 40.The physician had achieved certification for use of the exoseal vcd.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: 50936291
• Report Number: 9616099-2026-01405
• Device Sequence Number: 16139716
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: EX500
• Device Lot Number: 18499027
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 125 LB