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Model Number M0061903230 |
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 02/16/2024 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a tria soft ureteral stent was opened to be used to treat stone disease during a ureteroscopy laser lithotripsy procedure performed on (b)(6) 2024.Prior to procedure, it was noted that the stent was found cracked or broken.The procedure was successfully completed with another tria soft ureteral stent.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.
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Search Alerts/Recalls
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