(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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It was reported that the procedure was performed to treat a carotid artery.An unspecified stent was implanted in the target lesion.The 5.0x20mm viatrac plus rx balloon dilation catheter (bdc) was then advanced to perform post-dilatation; however, the bdc was losing pressure and the balloon was not inflating.The bdc was removed without reported issue, and another viatrac bdc was used to successfully complete the procedure.There were no adverse patient effects, and there was no clinically significant delay in the procedure.After the procedure concluded, the bdc was flushed to check the balloon and it was noted that there was a leak on the shaft, below the balloon.No additional information was provided.
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Internal file number (b)(4).Evaluation summary: a visual and functional inspections were performed on the returned device and the reported shaft leak and inflation issue were confirmed.It was reported that the procedure was performed to treat a carotid artery.It should be noted that viatrac 14 plus, global ce, instructions 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), 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 contributed to the reported leak and inflation issues.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.It is likely that the during advancement through the anatomy and/or other devices used during the procedure, the device became compromised or damaged causing the tear on the outer member ultimately resulting in the leak and inflation issue.In this case, the device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use.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 similar incidents reported from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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