Complaint conclusion: as reported, the angioguard (5 mm basket, medium support) had difficulty loading the filter.There was no reported patient injury.The product was not clinically used.One non-sterile angioguard (5 mm basket, medium support) was received for analysis inside a plastic bag.Neither the coil, capture sheath, nor original packaging were returned.Per visual analysis, the angioguard was received inserted into the deployment sheath and a torque device component was found affixed to the delivery wire.The angioguard filter basket was noted to not be docked (not loaded) into the deployment sheath.The angioguard basket and the tip of the unit were noted to be damaged.No other anomalies were noted.Per microscopic analysis, t the deployment sheath tip was noted to have kinked damage at the area where the basket is to be loaded.Also, the tip of the platinum coil (floppy wire) was noted to be bent/wavy and unraveled.The membrane of the angioguard was noted as smashed/ tangled.Device joints looked compressed/distorted and the membrane of the filter was noted to be separated/uplifted from the basket wire and prolapsed/folded over itself.No other anomalies were noted.Functional analysis could not be performed on the deployment sheath due to the damage on the angioguard and deployment sheath (distal tip- unraveled/stretched as well as filter basket- frayed/split/torn).Nonetheless, these damaged conditions on the angioguard and delivery sheath could not be conclusively determined during the analysis.A review of the device history records of lot #35228822 relative to the manufacturing, inspecting and packaging of the lot was performed.The history records indicate this product was final inspection tested and was determined to be acceptable.Records indicated that the product met specifications prior to shipment.The product event reported as ¿delivery system-loading (docking) difficulty¿, ¿distal tip- unraveled/stretched - during prep¿ and ¿filter basket- frayed/split/torn - during prep¿ were confirmed by analysis.Procedural and/or handling factors likely contributed to the noted damages on the unit since the device did not present with any obvious indication of a manufacturing defect or anomaly that could contribute to the event as reported.According to the precautions in the instructions for use (ifu), ¿guidewires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guidewire carefully for coil separation, bends, kinks, or damage of the filter basket assembly.¿ neither the device history record review nor the product analysis suggests that the failures are related to the manufacturing process; therefore, no corrective or preventive actions will be taken at this time.
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As reported, the angioguard (5 mm basket, medium support) had difficulty loading the filter.There was no reported patient injury.The product was not clinically used and will be returned for analysis.Per fal analysis, the tip of platinum coil (floppy wire) was observed bent/wavy and unraveled damage.The membrane of the angioguard was observed smashed/ tangled.Device joints looked compressed/not distorted.The membrane of filter was observed separated/ uplifted from the basket wire and prolapsed/ folded over itself.
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