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 12/05/2016 |
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 file.
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Event Description
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It was reported to boston scientific corporation that an rx cytology brush was opened for use during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2016.According to the complainant, during preparation, the brush failed to retract inside the catheter and when about to check the device, the bristled portion of the brush was attached in the opposite direction.The brush was unable to fit inside the plastic sheath.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no complication¿ at the conclusion of the procedure.
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Manufacturer Narrative
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Investigation results: analysis of the returned rx cytology brush found no issue with the bristled portion of the brush.The device was in opened or extended position when it was received.The brush bristled section was present, properly formed, and without issue.There were no kinks noted when the device was fully extended.Functional evaluation showed that the handle operated smoothly and the brush could be fully extended and retracted without issue.There is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the most probable root cause classification is "not confirmed." 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 opened for use during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2016.According to the complainant, during preparation, the brush failed to retract inside the catheter and when about to check the device, the bristled portion of the brush was attached in the opposite direction.The brush was unable to fit inside the plastic sheath.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no complication¿ at the conclusion of the procedure.
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Search Alerts/Recalls
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