It was reported that during preparation of the 5.0 x 60 mm armada 35 balloon catheter, an air leak was noted.Therefore, the balloon catheter was not used and exchanged for a new armada 35 balloon catheter.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Subsequent to the previously filed report, the following clarified information was provided: it was reported that during preparation of the 5.0 x 40 mm armada 35 balloon catheter, an air leak was noted.Therefore, the balloon catheter was not used and exchanged for a new armada 35 balloon catheter.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Visual and functional inspections were performed on the returned device.The leak was not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other complaints reported from this lot.The investigation was unable to confirm the reported leak during functional testing of the returned unit.It may be possible that there was a faulty connection with the syringe or inflation device, resulting in the leak; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5.Revised case description.D4.Catalog no.Part/number changed from b2050-060, 10712g1 to b1050-040, 10727g1.
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