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Model Number 140806 |
Device Problems
Break (1069); Device Difficult to Setup or Prepare (1487)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The fogarty corkscrew catheter was received in the laboratory for a full evaluation, as per product evaluation findings, spiral cable was exposed through a tear of approximately 1cm in length in the latex membrane.Edges of the torn region appeared to match up.There was no visible damage observed to the catheter body.It was able to move the thumb slide on the handle forwards and backwards and the membrane extended and contracted respectively.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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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Event Description
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As reported, during procedure with this fogarty corkscrew catheter, the handle was unable to be activated.As per product evaluation findings, spiral cable was exposed through a tear in the latex membrane.
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Manufacturer Narrative
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Updated: h4 (device manufacturer date), h6 (device code, component code, investigation findings, investigation conclusion).Added: h6 (type of investigation).Further investigation was performed by the engineers in the manufacturing site.As per product evaluation: "customer report of "handle was unable to be activated" was unable to be confirmed." and "it was able to move the thumb slide on the handle forwards and backwards and the membrane extended and contracted respectively." based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.All process parameters were met and inspections passed successfully.As part of the manufacturing process, a visual inspection is performed to catheters for general appearance, length of the tube, diameter of the bonding and spiral coil verification in closed position and inspection of the functionality of the handler is performed activating it 3 consecutive times to verify the behavior of the coils, spiral and latex membrane integrity.Additionally, per edwards instructions for use "exposure to the atmosphere, handling during insertion, and plaque and other deposits within the blood vessel may cause latex membrane degradation." and "to minimize the risk of vessel or membrane damage, do not exceed the maximum recommended pull force.".
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Search Alerts/Recalls
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