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 09/19/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Device code relates to problem code for the reported event of radiopaque marker detached.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 scraping cytology procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the radiopaque marker of the brush detached and was left inside the bile duct.The radiopaque marker was left to passed naturally.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 fine.
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Manufacturer Narrative
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Investigation results: visual analysis of the returned rx cytology brush found that the ro marker was not present and was not returned for evaluation.It was noted that there were indentation marks found at the ro marker section which indicates proper assembly during the manufacturing process.The complaint that the radiopaque marker detached was confirmed.Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification is operational context.
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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 scraping cytology procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the radiopaque marker of the brush detached and was left inside the bile duct.The radiopaque marker was left to passed naturally.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 fine.
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Search Alerts/Recalls
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