As reported, the user felt resistance while completely shuttling down an unknown mynxgrip vascular closure device (vcd) in an unknown sheath.When the mynx and sheath were retracted back, the shuttle tube was not in place.The sealant was attached on the wire.There was no reported patient injury.The product was not returned for analysis.A lot history review was not possible as the lot number was not provided.However, product release at cardinal health is contingent upon the successful completion of lot release testing and a documentation review by the quality department.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.According to the product instructions for use, users are instructed that while pulling lightly on the device handle (to ensure the balloon is abutting the arteriotomy or venotomy), open the procedural sheath stopcock and confirm temporary hemostasis.Blood within the device may cause the sealant to swell which will cause resistance as the user shuttles down.Without a lot number to conduct a product history record review, it is not possible to determine if the reported event could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.
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As reported, the user felt resistance while completely shuttling down an unknown mynxgrip vascular closure device (vcd) in an unknown sheath.When the mynx and sheath were retracted back, the shuttle tube was not in place.The sealant was attached on the wire.There was no reported patient injury.
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