Exact patient age unknown, but reported to be over 18 years of age.The event date reported is (b)(6) 2019; however, the procedure date reported is (b)(6) 2019.It is unknown what is the correct event/procedure date.The provided event date was chosen as a best estimate based on the report that the event occurred in (b)(6) 2019.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The initial reporter address is (b)(6).(b)(4).Visual analysis of the returned device found the distal section of the sheath (tip area of the sheath) was torn/split, this condition leaves the basket exposed.Additionally, the basket wires was found kinked.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device's performance and integrity.Handling and manipulation of the device during procedure could have kinked the basket wires.Also, interaction with the scope and additional devices could have torn the distal section of the sheath.Manufacturing processes includes extensive inspections to ensure that all finished devices meet specifications; however, there is no control how the devices are handle or manipulated in the field.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device has no influence on the event.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
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