It was reported that the procedure was to treat peripheral artery disease in the truncus and posterior tibial artery.An attempt was made to insert a 3.0x40mm armada 14 balloon catheter and a 2.5x40mm armada 14 into a 6f introducer sheath to perform kissing balloon technique.However, it was too tight so a 7f introducer sheath was successfully used.The 2.5x40mm armada 14 was advanced but failed to cross so it was exchanged for a 2.0x15mm armada xt to cross the lesion.After dilatation with both balloons, the 3.0x14mm armada 14 was removed from the anatomy by pulling on the hub.The majority of the balloon catheter was out of the introducer sheath when the hub detached from the catheter.The distal portion of the balloon catheter was simply removed from the patient anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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(b)(4).Evaluation summary: the device was returned for evaluation and the reported hub separation was confirmed.The difficulty inserting was not confirmed.Based on visual dimensional and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the difficulty inserting and hub separation are due to case circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.
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