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

Catalog Number	EX600
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use of a 6f exoseal vascular closure device (vcd) the indicator window did not change color.3 to 4 minutes of manual compression was then used instead.There were no reported injuries to the patient or signs of infectious disease.The device was being used for femoral artery closure.The operator had been trained to the device.No abnormalities were found before use.The device was stored and prepared according to the instructions for use (ifu), the procedure used a retrograde approach, and exoseal vascular closure device (vcd) was used in an interventional procedure.One exoseal device was used with a non-cordis sheath.Angiography confirmed femoral artery suitability, including appropriate 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, no nearby stent, no stenosis greater than 50% at or near the puncture site, no prior closure device use or manual compression at the target femoral site within 30 days, and no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site before exoseal vcd use.There was no difficulty connecting the non-cordis sheath with the exoseal vcd.The indicator wire cowling locked against the handle assembly with an audible click, pulsatile flow was observed from the bleed-back indicator, and the exoseal vcd and non-cordis sheath were retracted together until bleed back significantly slowed or stopped.During retraction, the physician's thumb was placed on the plug deployment button, no red color was seen in the indicator window, and when the device was removed from the patient, the indicator wire loop was deployed and visible with no anomalies noted.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Please note that the event date is currently unknown a review of the manufacturing documentation associated with lot 18448637 presented no issues during the manufacturing process that can be related to the reported event.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 ; 7863138372
• MDR Report Key: 25125440
• Report Number: 9616099-2026-00682
• Device Sequence Number: 8771556
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• UDI-Public: (01)10705032058858(17)270430(10)18448637
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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
• Device Catalogue Number: EX600
• Device Lot Number: 18448637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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: CORONARY BALLOON; CORONARY DRUG BALLOON; CORONARY GUIDEWIRE; CORONARY STENT; TERUMO 7F SHEATH
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 55 KG