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) stone removal procedure performed on (b)(6) 2023.During the procedure, a trapezoid rx basket was used in an attempt to crush a 1 cm stone.However, the handle broke and basket was unable to fracture the stone.Moreover, the tip of the basket did not deploy as intended, causing the basket to lodge in the patient's bile duct.A cre balloon was used to dilate the duct and ampulla, allowing the scope with the basket containing the stone to be remove from the bile duct.No patient complications were reported as a result of this event.
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Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device expiration and manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of handle break.Imdrf device cod a150301 captures the reportable event of tip failure to separate.Imdrf code f2301 captures the event of cre balloon was used to dilate the duct and remove the scope along with the basket containing the stone.
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