Model Number M00539230 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat a calculus of the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During implantation, the inner core of the delivery system was fractured and "it could not be used normally".The procedure was completed using another flexima biliary stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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H6: imdrf device code a0401 captures the reportable event of guide catheter break.
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Manufacturer Narrative
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Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h10: a flexima biliary stent and delivery system were returned for analysis.Visual examination of the returned device found the guide catheter detached and was not returned.The push catheter was also buckled, and the device was found with remnants of use.No other problems were noted to the delivery system.The reported event of guide catheter break was confirmed as the guide catheter was detached and was not returned.Taking all available information into consideration, the investigation concluded that the reported event and observed failure were likely due to factors encountered during the procedure.It may be that the remnants found stuck throughout the device and/or the excessive force applied, limited the performance of the device and contributed to the reported event and observed failure.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.Block h11: block e1 (initial reporter address 1 and initial reporter city) has been corrected.
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Event Description
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It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat a calculus of the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During implantation, the inner core of the delivery system was fractured and "it could not be used normally".The procedure was completed using another flexima biliary stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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