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Model Number 120403FP |
Device Problems
Material Fragmentation (1261); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Our product evaluation lab received one model 120403fp catheter without any attached components.The balloon was found to be torn at the proximal, distal side and tip of the balloon latex.The proximal and distal side of the torn edges did not appear to match up.The balloon did not inflate due to leakage through the torn area.The balloon latex appeared deteriorated.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 visible damage was observed from both windings or the catheter body.The customer report of the balloon did not inflate was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.
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Event Description
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It was reported that prior to use of a model 120403fp fogarty embolectomy catheter, the balloon did not inflate when tested.A tear was noted on the balloon.There were no patient complications reported.The date of the event is unknown.
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Manufacturer Narrative
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A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The root cause could not be associated to a manufacturing defect.As part of the manufacturing process controls, 100 percent of the units go through a balloon winding and visual inspection.In this inspection, the units are visually inspected to assess there are no bends, wrinkles, cuts, contamination, stains, deterioration, discoloration, or ripples.The instruction for use specifies the storage conditions for these catheters.A pra was previously generated to cover the balloons with fragmentations for embolectomy products.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 part of this monthly review.
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Search Alerts/Recalls
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