(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual inspection was performed on the returned device.The reported balloon rupture and balloon tear were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lots that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot or relabeled lots.The investigation was unable to determine a conclusive cause for the reported balloon rupture.The balloon tear appears to be related to operational context of the procedure.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 during a procedure of the heavily tortuous, heavily calcified, eccentric, de novo, mid common iliac, the armada 35 balloon was inflated at 10 atmospheres (atm), but ruptured.The device was removed from the anatomy without reported issue.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
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