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Model Number M00510880 |
Device Problem
Separation Failure (2547)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 03/02/2022 |
Event Type
Injury
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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.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, a trapezoid rx basket was used in an attempt to manually crush a stone.However, the basket failed to break the stone and the tip failed to detach.The catheter was cut and the basket was pulled out with a rat tooth grasper.Edema was noted and the procedure was aborted.No further information has been obtained despite good faith efforts.
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Event Description
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It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, a trapezoid rx basket was used in an attempt to manually crush a stone.However, the basket failed to break the stone and the tip failed to detach.The catheter was cut and the basket was pulled out with a rat tooth grasper.Edema was noted and the procedure was aborted.No further information has been obtained despite good faith efforts.
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Manufacturer Narrative
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Block h6: device code a150301 captures the reportable event of basket tip failure to separate.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the device was returned broken into pieces.The coil was broken and stretched, the working length was kinked, the side car rx was torn and detached.The tip is still attached to the basket.The thumb ring was broken from the handle and was not returned.However, the handle cannula is still attached.No other issues were noted.The reported event was confirmed.Based on all available information, it is possible that the manipulation or technique used at that time to interact with the device in conjunction with the tortuousness of patient's anatomy may have affected the device functionality.The state in which the handle broke and the device was returned into broken pieces suggest excess of force was applied.It was reported that the catheter was cut and the basket was pulled out with a rat tooth grasper, this explains why the device was returned broken into pieces.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Search Alerts/Recalls
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