(b)(4).The device was not returned to abbott vascular for analysis.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 revealed no other similar incidents reported for this lot.It should be noted that per instructions for use (ifu), the, viatrac 14 plus, global ce, states: the viatrac 14 plus peripheral dilatation catheter is intended to dilate stenosis in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries), and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.In this case, use of the device in the wrong anatomy does not appear to have caused or contributed to the reported balloon rupture.The device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.In this case, it is likely that during advancement though the heavily tortuous and heavily calcified anatomy, the balloon outer surface became damaged resulting in the reported balloon rupture during the first inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other rx viatrac balloon dilatation catheter referenced is filed under separate a medwatch report number.
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It was reported that two viatrac balloon dilatation catheters were prepared without issue.During a heavily tortuous and calcified right internal carotid intervention, both balloons ruptured during the first inflation below the rated burst pressure.Two xact stent systems were advanced, but failed to cross due to the heavily calcified anatomy.The procedure was completed with another rx viatrac plus 6x30 that was able to open up the lesion.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
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