The exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|
It was reported to boston scientific corporation that a jagtome rx 39 was in a procedure.According to the complainant, during the procedure, the cutting wire broke.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
|