Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned.A visual inspection found a partial circumferential shaft break under the strain relief at the distal end of the bifurcate.Functional testing was conducted and upon inflation, water was observed leaking at the break.Therefore, the investigation is confirmed for a break in the catheter shaft and the reported leak.The break in the outer shaft would have resulted in the reported leak.However, the definitive root cause for the break could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
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