As reported, the guidewire at the tip of the angioguard cannot be shaped.There were no reported patient injuries.Additional information obtained from the product evaluation states that the distal tip of the second angioguard was observed kinked/ bent and unraveled/stretched.Additional procedural details were requested but are unknown.Two non-sterile rx/5mm basket diameter/180cm embolic protection devices inside their deployment sheaths, a torque device and a capture sheath were received for analysis inside a plastic bag.Neither original packaging nor coil dispenser or capture sheath system was returned for analysis.Therefore, the analysis of the embolic protection device identified as device number one was analyzed and separately reported.Per visual analysis of this device it was indeed observed unraveled/stretched.No other anomalies found.Per microscopic analysis, the unit was observed under the vision system and it was confirmed distal tip unraveled/stretched.No anomalies found neither on the basket filter membrane nor on the struts of the basket of unit.A review of the manufacturing documentation associated with cordis lot # 35234216 part # 501814re was required to lake region medical representatives and the following was found: lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the above-mentioned lot.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The event reported by the customer as ¿distal tip (ecgw)- unraveled/stretched ¿was confirmed.However, the cause of the observed distal tip-unraveled/stretched condition on the unit could not be conclusively determined during the analysis.Procedural and/ or handling factors might have contributed to the observed distal tip- unraveled/stretched condition on the unit since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.In addition, the records indicated that the product met specifications prior to shipment.According to the instructions for use, which is not intended as a mitigation of risk ¿prior to the interventional procedure, all equipment and packaging, including the angioguard rx emboli capture guidewire system, should be inspected and examined carefully for defects.Check guidewire, filter basket, deployment sheath, capture sheath, and capture sheath rx port region (approximately 30 cm from the distal tip) for bends, kinks, or other damage.Do not use defective equipment.¿ the analysis results do not suggest that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.
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