Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the device was contaminated 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 trapezoid rx lithotripter basket was used in the bile duct during a biliary lithotripsy / endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a 3 cm stone.However, the handle cannula broke leaving the stone stuck inside the basket.The catheter was pulled at the level of the mouth to remove the device from the patient and the biliary tract was perforated.The procedure could not be continued.The patient was hospitalized and was recovering from pneumoperitoneum.
|