Catalog Number IGTCFS-65-UNI |
Device Problems
Kinked (1339); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/10/2013 |
Event Type
No Answer Provided
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Manufacturer Narrative
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(b)(4).Similar to device under 510(k) k090140.Summary of investigational findings: one photo was received.However, upon closer investigation it was noticed that this photo shows an intact filter.More information about the complaint was requested.It was stated that this picture may be wrong, but that the product and lot # received are correct.The returned filter is completely deformed.In two places kink are observed and in another place penetration of the sheath is seen.The penetration could explain that one of the primary legs is severely damaged with its secondary leg pushed towards the clip bushing.It has not been possible to determine what exactly the event description refers to, and based on all the above it has not been possible to conclude an exact root cause for the reported "the shape of filter is abnormal." it is known that tortuous patient anatomy can make advancement difficult and cause the sheath to kink.The filter has perforated the sheath.This is most likely due to excessive force used when trying to advance the filter through a kinked sheath.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to initial reporter: during the procedure, the product was implanted into the patient.When observed by contrast media, the doctor found the cycle of the filter was a bit abnormal.Then retrieved the product.And found the cycle of one leg was abnormal.Patient outcome: the patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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