It was reported that the procedure was performed to treat a non-calcified, non-tortuous left forearm fistula.The 5.0x20mm armada 35 balloon failed to deflate.After 3-5 minutes of attempting to deflate, the balloon partially deflated and was removed.A new unspecified balloon was used to successfully continue 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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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 lot revealed no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Without having the device to examine, the investigation was unable to determine a conclusive cause for the reported deflation difficulty.D10, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.
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