(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guide catheter was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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This is filed to report the torn soft tip found during returned device analysis.There was no reported device issue; however, the steerable guide catheter was returned with a torn, but intact, soft tip.
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(b)(4).Evaluation summary: all available information was investigated and the sgc (steerable guide catheter) was noted to have a torn soft tip.Tears in the soft tip is indicative of an interaction between the clip and sgc tip during retraction; however, the analysis was unable to replicate the difficulty retracting the clip into the returned sgc.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and a definitive cause for the tear in the soft tip could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.
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