Model Number M00545000 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/21/2014 |
Event Type
malfunction
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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 bile duct during an exfoliative cytodiagnosis procedure performed on (b)(6) 2014.According to the complainant, during the procedure, after the brush was inserted in the endoscope and into the bile duct, an attempt was made by the physician to push the brush out of the catheter.Resistance was met and brush would not come out.The physician applied force and the brush came out bent.The first brush was exchanged for another rx cytology brush which completed the procedure.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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(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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Manufacturer Narrative
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Visual evaluation of the returned device shows the brush and the working length was bent in several locations.Functional test was done and the brush was able to extend without issue but would not fully retract due to the bent brush.The device was inserted into the endoscope and resistance was met due to the bent areas in the working length.The device started kinking and could not pass through the endoscope.The complaint that the brush was bent was confirmed.Most probably, insertion of the device into the endoscope could have cause the brush and the working length to bend.The brush could not fully retract into the catheter due to the bent brush.Therefore, the most probable root cause of the failure identified is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no other complaints exist for the specified batch. .
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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 bile duct during an exfoliative cytodiagnosis procedure performed on (b)(6) 2014.According to the complainant, during the procedure, after the brush was inserted in the endoscope and into the bile duct, an attempt was made by the physician to push the brush out of the catheter.Resistance was met and brush would not come out.The physician applied force and the brush came out bent.The first brush was exchanged for another rx cytology brush which completed the procedure.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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