(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lots revealed no other incidents.The investigation determined the reported difficulties were due to case circumstances.The difficulty advancing and removing the guide wire through the armada 18 was due to the kinked tip which occurred due to the anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a moderately calcified proximal anterior tibial artery.A 2.5 x 60 mm armada 18 balloon dilatation catheter (bdc) was used; however, the tip of the catheter became kinked due to the anatomy.Therefore, a non-abbott guide wire could not advance through the bdc due to the kink.Both devices were then removed as a single unit as the armada bdc met resistance with the guide wire.A csi procedure was then performed with another unspecified bdc to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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