It was reported that when opened this 120804fp fogarty catheter was found to have the balloon popped.There was no patient injury.Our product lab received one 120804f catheter.The reported issue of the balloon popped was confirmed.The balloon latex appeared deteriorated.The balloon was completely torn around the distal windings.Multiple cracks were evident on the balloon latex.Both balloon windings were intact.The balloon latex was released from proximal winding to check the balloon edges at the tear.The edges did not appear to match at the tear.Latex deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.Appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon.No other visible damage was observed from the catheter body.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 corrective and preventive actions (capa) was created to address this issue.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.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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