Visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.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 was unable to determine a conclusive cause for the reported balloon rupture; however, the reported separation, foreign body in patient and serious injury 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.It was reported that the balloon was inflated a second time to 18 atmospheres.It should be noted that the armada 18 instruction for use states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure for this device is 14 atmospheres as indicated on the product label.In this case, since the balloon inflated successfully during the first inflation and as it could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture.
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