Model Number M0061921220 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a polaris¿ ultra stent was used during a ureteroscopy procedure performed in the ureter (date unknown).According to the complainant, during the procedure, the stent would not curl.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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.Reported event of "stent would not curl." the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a polaris ultra stent was used during a ureteroscopy procedure performed in the ureter (date unknown).According to the complainant, during the procedure, the stent would not curl.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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.(b)(4).During the procedure when the stent was placed, the pigtail of the stent would not curl and the stent could not be placed correctly.
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Search Alerts/Recalls
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