Model Number M00545000 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/06/2014 |
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 opened on (b)(6) 2014.According to the complainant, during preparation, severe resistance was encountered when the user attempted to retract the brush into the sheath.The brush was extended and retracted forcefully and the bristled portion came off.It was reported that the resistance was encountered during extension as well, and the resistance persisted after the brush detached.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 good.
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Manufacturer Narrative
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(b)(4) for the reported event of brush detachment.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 opened on (b)(6) 2014.According to the complainant, during preparation, severe resistance was encountered when the user attempted to retract the brush into the sheath.The brush was extended and retracted forcefully and the bristled portion came off.It was reported that the resistance was encountered during extension as well, and the resistance persisted after the brush detached.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 good.
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Manufacturer Narrative
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Investigation results: visual evaluation of the returned product found no anomalies.There were no kinks and bends present in the working length.The brush was securely attached to the drive wire.Functional evaluation found the device to extend and retract with no issue.The distance between the proximal end of the groove at the tip of the extrusion and the distal tip of the bristle was within specification.Measurement of the outer extrusion as well as brush extension meets specification.The complaint was not confirmed; the brush was present and intact, and no issues were encountered during actuation.The returned device showed neither evidence of the alleged issues, nor any defect which could have contributed to the event.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.
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Search Alerts/Recalls
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