The reported event of fogarty catheters seemed brittle and broke was confirmed.Balloon latex appeared discolored and deteriorated.Cracks and a tear were evident on balloon latex.Both balloon windings were intact.Balloon latex was released from proximal winding to check balloon edges at the tear.The edges did not appear to match at the tear.Balloon packaging was received folded.Catheter body, stylet and clear tube in the packaging were kinked.The location of the kinks were aligned to the location of the folds on the packaging.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The storage conditions for these catheters are specified in the ifu.A product risk assessment addresses balloons with fragmentations for embolectomy catheters, and a capa was generated to address balloon latex deterioration failure for embolectomy models with a vascupouch packaging and is currently in its implementation phase.The capa investigation concluded that the root cause is exposure of latex to ozone, which can happen when the pouch packaged device is stored in rooms with high energy ionizing radiation sources that could generate ozone e.G.Fluoroscopy machines, x ray machines, uv lights, hvac sanitation equipment, etc.As a result, fca 90905 was voluntarily initiated instructing customers to return any product which has been stored in the same room as high energy ionizing radiation sources which emit ozone.Based on the available information, there is no evidence that supports or confirms the failure mode of kink is associated to a manufacturing/design defect.No findings available and cause not established for kink.A device history record review was completed and documented that device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
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