Model Number M00545000 |
Device Problems
Detachment Of Device Component (1104); Patient-Device Incompatibility (2682)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 expired.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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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Event Description
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Note: this report pertains to one of two complaint devices used in the same procedure.Manufacturer report # 3005099803-2016-03586 and 3005099803-2016-03587 address both rx cytology brush.It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an exfoliative cytodiagnosis procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician encountered resistance when brush was advanced through the stricture.The distal tip of the brush was detached and was left inside the bile duct.An endoscopic sphincterotomy (est) was performed and expected that the distal tip would pass naturally.The procedure was completed with this 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 good.
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Manufacturer Narrative
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Investigation results: detailed analysis of the returned rx cytology brush revealed that the device bent and twisted at the distal end.The tip was found damaged and the pullwire was broken.The bristle portion of the brush was not returned and the cannula was in good condition.Functional evaluation found that the guidewire was loaded in the device and there was no resistance encountered.The brush could be extended and retracted without issue.The damage to the returned device was most likely due to tortuous anatomical and/or other operational factors encountered during the procedure.Therefore, the most probable root cause classification is "operational context.".
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Event Description
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Note: this report pertains to one of two complaint devices used in the same procedure.Manufacturer report # 3005099803-2016-03586 and 3005099803-2016-03587 address both rx cytology brush.It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an exfoliative cytodiagnosis procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician encountered resistance when brush was advanced through the stricture.The distal tip of the brush was detached and was left inside the bile duct.An endoscopic sphincterotomy (est) was performed and expected that the distal tip would pass naturally.The procedure was completed with this 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 good.
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Search Alerts/Recalls
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