The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not used past its expiry.Device component code relates to device problem code for the reported event of brush bent.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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This report pertains to the second of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-00469 for the other associated device information.It was reported to boston scientific corporation that two rx cytology brushes were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the bristled portion of the brush was bent and the devices failed to advance through the scope.It was also reported that the brush was unable to retract inside the catheter.The procedure was completed with a different device.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.
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