Model Number M00545000 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician had difficulty in advancing the brush through the bile duct.They checked the device and noticed that the plastic sheath was kinked.The procedure was completed with another rx cytology brush.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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Manufacturer Narrative
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Visual evaluation of the returned device revealed that the working length was kinked from the distal end.The brush bristle portion was present, properly formed and within specification.The kink in the device and the difficulty in engaging the target vessel were most likely due to some aspects of tortuous anatomy or other operational factors of the procedure.Therefore, the most probable root cause classification is "operational context".A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
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Event Description
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It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician had difficulty in advancing the brush through the bile duct.They checked the device and noticed that the plastic sheath was kinked.The procedure was completed with another rx cytology brush.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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Search Alerts/Recalls
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