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

Catalog Number	EX700
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during withdrawal of a 7f exoseal vascular closure device (vcd), the indicator window did not turn black at any point, even until the device was withdrawn from the patient¿s body.Manual compression was held for 13 minutes to complete the procedure.There were no reported injuries to the patient.The device was stored and prepared according to the instructions for use (ifu).The exoseal vascular closure device (vcd) was used in an interventional procedure using a retrograde approach, and the physician had achieved certification for use of the exoseal vcd.The patient¿s body mass index (bmi) was not greater than 40.There were no visible signs of device or package damage prior to use, and one exoseal device was used.A 7f non-cordis sheath was used.Femoral artery suitability was verified by angiography, including a 30¿45 degree 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 stent near the puncture site, no stenosis greater than 50% at or near the puncture site, no closure device or manual compression at the target femoral site within 30 days prior to the procedure, and no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to exoseal vcd use.There was no difficulty connecting the vascular sheath introducer with the exoseal vcd.The indicator wire cowling locked onto the handle assembly with an audible click, pulsatile flow was observed from the bleed-back indicator, and the exoseal vcd and vascular sheath introducer were retracted together until bleed-back significantly slowed or stopped.The physician did not place a thumb on the plug deployment button during retraction.The indicator window did not show red during retraction.When the device was removed, the indicator wire loop was deployed/showing, with no anomalies noted.The device will not 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.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: 50947495
• Report Number: 9616099-2026-01412
• Device Sequence Number: 9534683
• Product Code: MGB
• UDI-Device Identifier: 10705032058896
• 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): 09/30/2026

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: EX700
• Device Lot Number: 18504762
• Was Device Available for Evaluation?: No
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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: 7F Terumo sheath; angiography guidewire; coronary angiography catheter
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 136 LB