(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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(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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