EXOSEAL
Received Jul 14, 2026 · Event occurred Jun 16, 2026
Report 9616099-2026-00979 · MDR key 25814272
Device
Generic name
Device, Hemostasis, Vascular
Manufacturer
Cordis Us. CorpModel number
NACatalog number
EX600
Lot number
18399232
Product problems
- Defective Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED, NO COLOR CHANGE WAS OBSERVED IN THE INDICATOR WINDOW OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) AFTER OBSERVING A SIGNIFICANT REDUCTION IN PULSATILE BLOOD FLOW AND WITHDRAWING THE SYSTEM FURTHER. THE PLUG WAS NOT ABLE TO BE RELEASED SO MANUAL COMPRESSION WAS USED FOR HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED IN AN EMERGENCY THROMBECTOMY PROCEDURE. THE ACCESS SITE WAS THE FEMORAL ARTERY. 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.