(b)(4).Visual examination of the returned device revealed that the distal pierced hole of the working length was found torn, which displaced the cutting wire/notch from its original position.The dislodged wire anchor prevents the device from being able to bow; consequently, confirming the reported complaint.It was found during the investigation of the returned device that the distal pierce hole was torn, which is evidence that cutting wire anchor slipped out causing the catheter to tear.Based on above information, there is no evidence of a manufacturing issue related.This type of damage is associated with a known design limitation of the device generated by mechanical tear when the cutting wire/anchor is tearing through distal pierce hole and continuing down through the ptfe catheter.Therefore, the most probable cause for this complaint will be assigned as design inadequate for purpose, since the problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.There is an open investigation to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
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It was reported to boston scientific corporation that a hydratome rx 44 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 technician was instructed to bow the tome; however, the cutting wire was unable to bow after the generator was activated and the current was applied.The procedure was completed with a second hydratome rx 44.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.This event has been deemed a reportable event based on the investigation results; wire/anchor dislodged.
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