MYNXGRIP
Received Jul 13, 2026 · Event occurred Jun 22, 2026
Report 3004939290-2026-00905 · MDR key 25796226
Device
Generic name
Device, Hemostasis, Vascular
Manufacturer
Cordis Us. CorpCatalog number
MX5021
Lot number
F2607703
Product problems
- Failure to Fire
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED, THE PLUG OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) COULD NOT BE RELEASED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THE STORAGE TEMPERATURE DID NOT EXCEED 25 °C. THE MYNX VASCULAR CLOSURE DEVICE (VCD) WAS USED IN AN INTERVENTIONAL PERIPHERAL PROCEDURE WITH AN ANTEGRADE APPROACH, AND THE DEPLOYER WAS MYNX CERTIFIED. SUITABILITY OF THE FEMORAL ARTERY WAS VERIFIED ON ANGIOGRAPHY, THE DEVICE WAS USED IN THE FEMORAL ARTERY, AND THE VESSEL DIAMETER WAS CONFIRMED TO BE GREATER THAN OR EQUAL TO 5 MM. THERE WAS NO VESSEL TORTUOSITY AND NO PERIPHERAL VASCULAR DISEASE (PVD) OR CALCIUM NEAR THE PUNCTURE SITE. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION FOR 20 MINUTES. THE USER SHUTTLED DOWN COMPLETELY, THERE WAS NO SIGNIFICANT RESISTANCE DURING SHUTTLING, NO UNUSUAL FORCE WAS APPLIED WHEN RETRACTING THE SHEATH, AND THE ADVANCER TUBE WAS ENGAGED/VISIBLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.