(b)(4).The returned sensation short throw was analyzed, and a visual evaluation noted that the loop was broken with evidence of a burned wire.The working length was measured and was found to be within specification.No other visual failures were noted.The investigation findings revealed the loop was broken, consequently confirming the reported event "wire broke".The investigation concluded that the observed failure was likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated and/or the technique used by the physician during initial use of set-up or power-up, limited the performance of the device and contributed to the broken loop.Additionally, the broken loop may occur due to an excessive application of power during the cauterization process; the loop may overheat causing it to break.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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It was reported to boston scientific corporation that a sensation short throw was used during a procedure performed on (b)(6) 2020.According to the complainant, during preparation, the wire broke off when the snare handle was manipulated before the procedure.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.
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