The device was not returned for evaluation.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 identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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It was reported that during un-packaging of the 2.0 x 40 mm armada 18 balloon catheter, the tyvek pouch was already opened.The external box was not damaged or crushed.The balloon catheter was not used, and a new device was used to continue the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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