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 revealed no other similar incidents.Based on the information provided, the balloon rupture appears to be due to case circumstances.It is likely that the resistance during advancement and rupture occurred due to interaction with the stent.Based on the information provided, the balloon rupture appears to be due to case circumstances.It is likely that the resistance during advancement and rupture occurred due to interaction with the stent resulting in the difficulty to advance.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 a 12x40mm armada 35 balloon catheter was being used to treat an in-stent restenosis in the common iliac artery.Resistance was felt between the balloon and the unspecified stent, and the balloon ruptured during the first inflation at 6 atmospheres.The balloon catheter was removed, and the procedure was successfully completed with a 10x20mm armada 35 balloon catheter.The physician reported that the rupture was possible due to interaction with the stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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