As reported, the balloon on a 6/7f mynx grip vascular closure device (vcd) popped upon pulling the device back.Hemostasis was achieved with manual pressure.There were no reports of patient injury.The device was used in an interventional procedure.The procedure used a retrograde approach.The deployer was mynx certified.A 6f 11cm cordis avanti+ sheath introducer was used.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5mm in diameter.The vessel was moderately tortuous and there was moderate presence of pvd/ calcium in the vicinity of the puncture site.The mynx vcd was stored and prepped according to the instructions for use (ifu).There was no prior pta, stent, or vascular graft in the common femoral artery or vein.There was no visible damage to the distal end of the sheath after removal.The device is not being returned because the infection status of the patient cannot be confirmed.
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Complaint conclusion: as reported, the balloon on a 6f/7f mynxgrip vascular closure device (vcd) popped upon pulling the device back.Hemostasis was achieved with manual pressure.There were no reports of patient injury.The device was used in an interventional procedure.The procedure used a retrograde approach.The deployer was mynx certified.A 6f 11cm cordis avanti+ sheath introducer was used.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5mm in diameter.The vessel was moderately tortuous and there was moderate presence of peripheral vascular disease (pvd)/ calcium in the vicinity of the puncture site.The mynx vcd was stored and prepped according to the instructions for use (ifu).There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.There was no visible damage to the distal end of the sheath after removal.The device was not returned because the infection status of the patient could not be confirmed.The reported event of ¿balloon-balloon loss of pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue experienced could not be determined.Based on the information available for review, access site vessel characteristics (there was moderate presence of pvd/calcium within the vicinity of the puncture site and moderate tortuosity) most likely contributed to the rupture reported since calcification/pvd at the access site can cause damage to the balloon, resulting in a loss of pressure.According to the mynxgrip ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynxgrip have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram or venogram: common femoral artery or vein single wall puncture.Evidence of adequate flow.There is no evidence of significant pvd in the vicinity of the puncture.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.Based on the information available for review, there is no indication to suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
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