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
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, after the procedure, the operator performed femoral artery closure with the 6f exoseal vascular closure device (vcd).However, the indicator window did not change color.Manual compression was then used instead.The patient was not injured.The operator had been trained.No abnormality was found before use.The exoseal vascular closure device (vcd) was stored, inspected, handled, and prepared according to the instructions for use (ifu).No abnormalities were noted prior to use.A retrograde approach was used, and angiography confirmed femoral artery suitability, including appropriate sheath insertion angle.The vessel diameter was verified to be at least 5 mm and no calcium, plaque, stent, or significant stenosis at the puncture site.A 6f non-cordis sheath introducer was used.No resistance or excessive force occurred during advancement or insertion, and there was no difficulty connecting the sheath introducer to the device.The sheath engaged and locked with the indicator wire cowling with an audible click, and pulsatile blood flow was observed.Although retraction was performed as instructed, the indicator window did not display a solid black color.The device remained securely locked with the sheath introducer.The device will not 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: 25134936
• Report Number: 9616099-2026-00698
• Device Sequence Number: 9480318
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• UDI-Public: (01)10705032058858(17)270331(10)18438976
• 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): 05/26/2026

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: 18438976
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/17/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2025
• 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: 6F TERUMO; CORONARY BALLOON; CORONARY DRUG BALLOON; CORONARY GUIDEWIRE; CORONARY STENT; TERUMO 7F SHEATH
• Patient Age: 65 YR
• Patient Sex: Female