(b)(4).The device was not returned 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 identified no other complaints.It should be noted that the indication for use listed in the viatrac plus instruction for use 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).In this case, it could not be determined if the off-label use caused or contributed to the reported difficulties.Based on the information provided, a definitive cause for the reported balloon rupture and separation could not be determined.It may be possible that the rupture occurred due to interaction with lesion calcification or associated devices.Additionally, the separation may have occurred during removal due to the ruptured balloon material catching on the introducer sheath; however, this could not be confirmed.The additional treatment to snare the separated portion of the balloon was due 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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