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 Date 02/07/2018 |
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 filed.
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Event Description
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It was reported to boston scientific corporation that an rx cytology brush was prepared to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during preparation, when the brush was advanced out of the catheter, the device was difficult to retract.It was also reported that the wire inside the sheath was broken.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Investigation results: a visual evaluation of the returned rx cytology brush revealed that the pull wire was broken at the distal end of the handle cannula, and it was also noticed that a kink was found in the same location.Further evaluation noted that the extrusion is free of obvious kinks and bends.A functional analysis was not performed due to the condition of the returned device.It is most likely that the pull wire being kinked at the distal end of the handle cannula could have caused difficulty to retract the brush.Due to excessive manipulation of the device, it would cause the pull wire to break.Based on all gathered information, the most probable cause of this complaint is ¿manufacturing process design¿, since it is most likely due to design or validation of the manufacturing process not being sufficient to ensure that the finished device met the intent of the design.There is an investigation in place to address this issue.A review of the device history record (dhr) was performed and no deviations were found.
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Event Description
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It was reported to boston scientific corporation that an rx cytology brush was prepared to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during preparation, when the brush was advanced out of the catheter, the device was difficult to retract.It was also reported that the wire inside the sheath was broken.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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