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Model Number M00510880 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the reported date of (b)(6) 2022.(b)(4).
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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 common bile duct during the removal of gallstones procedure.During the procedure, a trapezoid rx was used in an attempt to crush a 1.5cm stone, however, the tip of the basket did not detach from the basket.Another attempt was made with an alliance handle attached to the handle of the trapezoid basket; however, the tip of the basket still did not detach.Finally, by wiggling and moving the basket around the gallstone, the stone came out of the basket.The basket was removed from the patient and the procedure was completed successfully with another trapezoid rx.There were no patient complications reported as a result of this event.
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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 common bile duct during the removal of gallstones procedure.During the procedure, a trapezoid rx was used in an attempt to crush a 1.5cm stone, however, the tip of the basket did not detach from the basket.Another attempt was made with an alliance handle attached to the handle of the trapezoid basket; however, the tip of the basket still did not detach.Finally, by wiggling and moving the basket around the gallstone, the stone came out of the basket.The basket was removed from the patient and the procedure was completed successfully with another trapezoid rx.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the reported date of november 18, 2022.Block h6: device code a150301 captures the reportable event of tip failure to separate.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation observed that the handle cannula was kinked, the sheath was buckled, and the tip still attached to the basket.The reported event was confirmed.Based on all available information, it is possible that the technique used, the tortuosity found during the procedure or the patient's anatomical conditions may have affected the functionality causing a problem to detach the tip.The kinked handle cannula suggests that excess force was applied.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.A labeling review was performed and from the information available the device was used per the instructions for the use (ifu)/product label.
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Search Alerts/Recalls
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