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Model Number M0063901050 |
Device Problems
Material Deformation (2976); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/01/2020 |
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 date that the manufacturer became aware of the event.(b)(4).Visual inspection of the returned device found the sheath was bent in several location of the working length.The tip of the sheath was inspected under magnification and it was observed that the sheath was torn at the distal section of the device.Functional inspection found the basket was able not able to extend and retract properly.Based on all available information, the investigation concluded that the handling and manipulation of the device during it use can lead to sheath torn at the distal section of the device.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
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Event Description
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It was reported to boston scientific corporation that a zero tip basket was used in the ureter during a ureteroscopy procedure performed on an unknown date.According to the complainant, during the procedure, there was difficulty opening and closing the basket until it would no longer open.The procedure was completed with another zero tip basket.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.The investigation results revealed that the sheath was torn at distal end; therefore, this is now an mdr reportable event.
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Search Alerts/Recalls
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