Model Number M00545000 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a biliary rx cytology brush wireguided was to be used in an unknown procedure on (b)(6) 2018.According to the complainant, during preparation and outside the patient, it was noticed that the bristled portion of the brush was bent.The procedure was completed with another biliary cytology brush.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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H6: problem code 2981 captures the reportable event of brush bent.H10: investigation analysis: analysis of the returned device revealed that there were no visual defects noted, the returned device looks under good conditions without evidence of damages.No bent, kinked or deformed sections were noted.The brush bristle and the distal section (tip) of the product presented no issues.Based on the information available and the analysis performed, the most probable root cause classification is no problem detected.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
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Event Description
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It was reported to boston scientific corporation that a biliary rx cytology brush wireguided was to be used in an unknown procedure on (b)(6) 2018.According to the complainant, during preparation and outside the patient, it was noticed that the bristled portion of the brush was bent.The procedure was completed with another biliary cytology brush.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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