The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a captiflex small oval flexible snare was used during a procedure performed on an unknown date.According to the complainant, during the procedure, there was the same known issue with the handle and the device was not cutting through the tissue.It was not reported whether the procedure was completed and it was not reported how it was completed.The patient's current condition is unavailable.
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