The device history record review confirms that the device met all material, assembly, and performanc e specifications.Visual and microscopic examination of the returned device found that the distal and proximal stent delivery catheter was noted to be kinked.The proximal stabilizer was kinked.The rhv was loosened and it was noted that the stabilizer was broken.The stent was found to be partially deployed.Functional testing could not be performed due to the anomalies found on the device.Based on the analysis, the reported event was confirmed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the investigation results and available information, it is possible that the anatomical factors present during the clinical procedure caused the damage to the device and the reported defects.Therefore, a cause of procedural factors and error usage have been assigned to this investigation.
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