PRUITT AORTIC OCCLUSION CATHETER 2100-12

[3462055] The pt in this case was under emergency care for a ruptured suprarenal aaa. The physician requested the aortic occlusion catheter. The required pre-use check of the device was not conducted. The device was placed in the pt and the balloon would not stay inflated to occlude the vessel. The physician used a traditional clamp and subsequently repaired the vessel. The pt was stabilized. The physician finished the procedure and the pt left the operation room. The pt later expired in the icu. We were not able to get confirmation from the physician as to whether the failure of the pruitt aortic occlusion catheter contributed or not to the death of this pt. We therefore are submitting this report based on the regulations set forth in 21 cfr 803. 56.
Patient Sequence No: 1, Text Type: D, B5

[10686861] We have received the complaint device for eval. We were able to verify and confirm the failure. We have found that the balloon had holes and was degraded. The root cause of balloon degradation remains inconclusive. However, sometimes signs of degradation appear before shelf life expiration due to storage conditions (the heat, light and/or humidity experienced by the packaging and the device prior to use). Since natural rubber latex is acted on by environmental conditions, we always recommend storage of our products in a cool dark area away from fluorescent lights, sunlight and chemical fumes to prevent premature deterioration of the rubber balloon (please ref lemaitre vascular, inc ifu for more details). Lot history records review did not reveal any discrepancies related to the complaint event during either the manufacturing or the packaging processes. Please note that the physician confirmed that the pre-use check was not conducted. The ifu requires the conduct of a pre-use check to verify that the balloon is functional and not leaking.
Patient Sequence No: 1, Text Type: N, H10