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 04/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 used in the bile duct during a biopsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician attempted to brush the bile duct.When tissue was obtained, the device was removed while leaving the guide wire and tube stent extended.Fluoroscopy showed that a radiopaque marker remained inside the patient.The radioopaque marker was detached from the brush and was passed naturally after the deployment of metallic stent.The procedure was completed with this device.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 analysis of the returned rx cytology brush revealed that the catheter guidewire lumen was torn through from the distal u-channel marker to the catheter distal dip.The ro marker was missing and the brush was in retracted position.Functional evaluation found brush would fully extend and retract without difficulty.The brush bristle section of the wire had been cut and was not returned.The complaint that the radiopaque marker detached was confirmed.Based on the product analysis, most likely the customer did not follow the guidance in device removal section of the directions for use, which instructs the user to perform a standard device exchange.In this case it appears the user performed a tear-away exchange; therefore, the most probable root cause for the reported complaint is user/use error.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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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 a biopsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician attempted to brush the bile duct.When tissue was obtained, the device was removed while leaving the guide wire and tube stent extended.Fluoroscopy showed that a radiopaque marker remained inside the patient.The radioapaque marker was detached from the brush and was passed naturally after the deployment of metallic stent.The procedure was completed with this device.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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