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Model Number 120805FP |
Device Problems
Degraded (1153); Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Our product evaluation lab received one model 120805f embolectomy catheter.The customer report of balloons failed was confirmed.Balloon latex appeared deteriorated.Multiple cracks and tears were evident on balloon latex.Leakage was observed through the tears on the balloon.Both balloon windings were intact.Balloon latex was released from proximal winding to check balloon edges at the tears.The edges did not appear to match at the tears.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 catheter body.A capa was initiated for this issue and a product risk assessment was needed.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 to address this issue 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.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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Event Description
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It was reported that the customer had an incident on november 1, 2023, where an embolectomy catheter balloon failed during a procedure.The 1.5 ml of liquid was used as ifu requires and the balloon burst upon use.Fogarty arterial embolectomy catheter, catalog # 120805fp, lot # 64493859.Case was completed using alternative methods.The catheter was not stored in a room where ultraviolet cleaning units are used.There was no allegation of patient injury.
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Manufacturer Narrative
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Our product evaluation lab received one model 120805f embolectomy catheter.The customer report of balloons failed was confirmed.Balloon latex appeared deteriorated.Multiple cracks and tears were evident on balloon latex.Leakage was observed through the tears on the balloon.Both balloon windings were intact.Balloon latex was released from proximal winding to check balloon edges at the tears.The edges did not appear to match at the tears.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 catheter body.A capa was initiated for this issue and a product risk assessment was needed.An engineering evaluation was performed 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 to address this issue was completed.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.Corrective actions have been implemented.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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Search Alerts/Recalls
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