It was reported that during a procedure of the left superficial femoral artery (sfa) after device preparation the 6 x 40 mm armada 35 balloon dilatation catheter (bdc) was used for post-dilatation of the implanted unspecified stent, however, the balloon during the inflation attempt at 10 atmosphere (atm) appeared to not fully inflate in the middle portion.The bdc was removed from the anatomy and re-inserted for a second dilatation.The bdc was inflated at 10 atm three times for post-dilatation, but after pulling negative to go to neutral with the indeflator the balloon did not deflate.The indeflator was switched to a 60 cc syringe to facilitate deflation, but the balloon did not deflate in the anatomy.The sheath was pushed forward and the balloon was carefully and completely enclosed in the sheath while inflated without issue.After removal from the anatomy and from the sheath, it was noted that the balloon had deflated flat and was not rewrapped.No additional dilatation was performed to the vessel.There was no reported adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported deflation issue was unable to be confirmed.The flat balloon refold was confirmed.Based on a visual dimensional and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.
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