It was reported that the procedure was performed to treat a lesion with heavy calcification, moderate tortuosity, and 80% stenosis in the femoral artery.Reportedly, a 6.0 x 100 mm armada 35 balloon dilatation catheter (bdc) was advanced for dilatation; however, resistance was felt due to the anatomy and the balloon ruptured during first inflation at nominal pressure.During removal, resistance was noted with the sheath and the distal part of the balloon separated and remained in the artery.An absolute stent was deployed to cover (embed) the separated balloon material to avoid distal embolization.A new 7.0 x 120 mm armada 35 bdc was then advanced to expand the stent but the balloon ruptured during the first inflation at nominal pressure.On removal, resistance was noted with the sheath and the distal part of the balloon separated and remained in the artery.Another absolute stent was deployed to cover (embed) the separated balloon material.An unspecified bdc was then used and the target lesion was treated.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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Visual analysis was performed on the returned device.The reported balloon rupture and separation was confirmed.The difficulty removing was not tested due to the condition of the device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the balloon rupture was the result of interaction with the heavily calcified lesion.It is likely that the rupture initiated longitudinal.In addition, the resistance noted during removal and radial separation of the balloon was likely the result of the ruptured balloon material catching on the introducer sheath during removal.The additional medical intervention to embed the separated balloon material using an absolute stent was related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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