It was reported that the procedure was to treat the right common iliac artery.An 8x40mm armada 35 balloon was already used in left common iliac and inflated once without issue.Then it was advanced to the right common iliac and inflated once at 8 atmospheres, but burst at nominal pressure.As the device was being removed, resistance with the anatomy was met and the balloon itself separated.A snare was used to retrieve the separated balloon.No portion of the device remains in the patient.No further device was used as the armada 35 completed the procedure before the issues occurred.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
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The device was not returned for evaluation.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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported balloon rupture, entrapment of device or device component, separation, unexpected medical intervention, and removal of foreign body appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.D9,h3: device status changed from returning to not returned.
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