Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.However, the analysis identified the inner and outer member was stretched and bunched distal to the mid lap seal.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 similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported inflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
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It was reported that the procedure was to treat a de novo, moderately calcified, mildly tortuous lesion in the left anterior descending (lad) artery.The 4.0x20 mm nc trek balloon dilatation catheter (bdc) was able to hold pressure but could only partially inflate inside the previously implanted stent.There was no difficulty in removing the stylet or protective sheath.Another nc trek bdc was used to successfully complete the procedure.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified a stretched inner/outer member.No additional information was provided.
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