(b)(4).The returned trapezoid rx basket was analyzed, and a visual evaluation noted that the side car rx was damaged.A dimensional inspection found the side car rx was pushed back approximately 1.0mm, which is out of specification.No other issues were noted.The reported event was confirmed.Based on all available information, it is possible that manipulation or technique used to interact with the device in conjunction with the tortuous anatomy has caused damage to the distal end of the side car rx, resulting in the inability of the guidewire to pass through.Also, it was found that the side car rx was pushed back suggesting that the device was subjected to possible resistance during procedure.Therefore, the most probable root cause for the problem reported and the problems discovered during analysis is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the guidewire failed to pass through the side car rx (guidewire channel).Another trapezoid basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Investigation results revealed the side car rx was pushed back; therefore, this is now an mdr reportable event.
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