The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device 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.
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It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct and papilla during an endoscopic retrograde cholangiopancreatography 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 12-15mm stone, but was unsuccessful.Additionally, the tip failed to detach from the basket to release the stone.The basket was then cut below the handle to expose the inner wire and advance the soehendra lithotripter; however, it could not be advanced due to the sheath.The scope was withdrawn from the basket, and a 12-15mm cre balloon was used to dilate the distal common bile duct and papilla.This allowed for successful removal of the basket with the impacted stone from the patient.There were no patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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