During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: cruise, farbid.Guide catheter: distine 6f 45cm.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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(b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the reported resistance and balloon rupture appears to be due to case circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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