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Model Number M0061802310 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Block b3: date of event was approximated to february 1, 2024, based on the date the manufacturer became aware of the event.Block h6: imdrf device code: a0501 captures the reportable event of coil detached, inside the patient.
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Event Description
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It was reported to boston scientific corporation that a contour ureteral stent was used to treat stones during a ureteroscopy procedure in the kidney.The event date was unknown.During the procedure, when the stent was inserted, it was found broken.The procedure was successfully completed with another contour ureteral stent.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 good.A photo of the complaint device was provided and showed that the coil was detached.
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Search Alerts/Recalls
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