Exemption number e2019001.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 similar complaints.Based on the information provided, the reported balloon rupture appears to be due to case circumstances.It is likely that the rupture occurred due to interaction with lesion calcification causing damage to the outer surface of the balloon and rupture during inflation.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 performed to treat a re-stenosed lesion in the heavily calcified, non-tortuous, 80% stenosed popliteal artery.A 5x100mm armada 18 percutaneous transluminal angioplasty balloon ruptured at 10 atmospheres during the first inflation.A non-abbott balloon was used 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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