Model Number M00545000 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Reported event of wire broken.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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, the brush ¿went¿ broke during the procedure.There were no known patient complications reported as a result of this event.
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Manufacturer Narrative
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Investigation results: visual evaluation of the returned device found no anomalies.The brush bristled portion was present, properly formed and without issue.Functional analysis showed that the device could be extended however, resistance was noted.The device handle was disassembled and revealed that the pull wire was bent and broken at the hypotube joint.Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification for the reported failure 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 other 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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, the brush ¿went¿ broke during the procedure.There were no known patient complications reported as a result of this event.
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Search Alerts/Recalls
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