MYNX CONTROL

Description of Event or Problem

As reported, the sealant of a 5F Mynx Control vascular closure device (VCD) was deployed, but bleeding did not stop and the product was not available. Manual compression was performed, and recovery was reported. There was no reported patient injury. Pulsatile bleeding was noted at the puncture site immediately upon removal of the advancer tube, and the sealant was deployed to the proper location. No anticoagulants, antiplatelets, or thrombolytics were used. The patient had no history of coagulopathy. No issues were noted during balloon retraction or the Button #2 step. The Mynx vascular closure device (VCD) was used in transfemoral cerebral angiography (TFCA), which was reported as a diagnostic procedure. The procedure used a retrograde approach. The deployer was Mynx certified and had used the device several times before this procedure. A 5F non-Cordis sheath introducer was used. There were no visible signs of device or package damage prior to use. The Mynx vascular closure device (VCD) was prepared according to the instructions for use (IFU). The femoral artery¿s suitability was verified on angiography, including the insertion angle of 30 to 45 degrees for the vascular sheath introducer. The vessel diameter was verified to be at least 5mm. No vessel tortuosity was present. The stick location was the common femoral artery (CFA). The puncture site did not have visible calcium, plaque, or peripheral vascular disease. There was no stent near the puncture site. The vessel did not have stenosis greater than 50% at the puncture site. The target femoral site was not previously closed with any closure device less than 30 days before this procedure. There was no evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site before use of the Mynx Control vascular closure device (VCD). Hemostasis was achieved using manual compression. The device will be returned for evaluation.

Additional Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.