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Model Number M00539310 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block h6: imdrf impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.
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Event Description
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It was reported to boston scientific that a flexima biliary stent was attempted to be placed in the distal bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(4)2023.During the procedure, after the guidewire was correctly positioned, an attempt was made to cross the stenosis, but despite several maneuvers, the physician was unable to cross the stenosis.After several attempts, the procedure was cancelled.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable.
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Event Description
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It was reported to boston scientific that a flexima biliary stent was attempted to be placed in the distal bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, after the guidewire was correctly positioned, an attempt was made to cross the stenosis, but despite several maneuvers, the physician was unable to cross the stenosis.After several attempts, the procedure was cancelled.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: imdrf impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned flexima biliary stent and delivery system were analyzed, and a visual evaluation noted that the delivery system and stent were free of obvious kinks and bends.Additionally, the outer diameter of the push catheter and the outer diameter of the stent were measured and both components were found within manufacturing specifications.No other problems with the device were noted.Therefore, the reported event of stent difficult to advance was not confirmed.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Considering all available information, the returned device met all manufacturing requirements, and no abnormalities were reported during the manufacturing process.The device did not show evidence of either the alleged problem or any defect that could have contributed to the event reported.Therefore, the most probable cause is no problem detected.
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Search Alerts/Recalls
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