Qn#(b)(4).Evaluation: the reported complaint of unable to aspirate/flush central lumen is not confirmed.However, the device was found kinked and had numerous bends to the central lumen which may have caused the reported complaint.The root cause of the kink/bends is undetermined.The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." a device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex will continue to monitor for similar reported complaints.Other remarks: conclusion: the reported complaint of unable to aspirate/flush central lumen is not confirmed.However, the device was found kinked and had numerous bends to the central lumen which may have caused the reported complaint.The root cause of the kink/bends is undetermined.
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