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Model Number M0063901050 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 zero tip basket stone retrieval basket was to be used in the ureter during a ureteroscopy procedure performed on (b)(6) 2022.During procedure, the sheath was found broken and peeled at the distal end.Additionally, the basket wire was broken.The procedure was completed with another zero tip basket.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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