The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(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 mdr will be filed.
|
It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the trapezoid rx basket was passed down the scope.However, the tip of the basket prematurely detached before passing the device into the common bile duct.The tip of the basket was not retrieved and the procedure was completed without the use of a basket.There were no patient complications as a result of this event.
|