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Model Number M0061456130 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/18/2015 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that an ascerta¿ stent that was previously implanted in the ureter (date unknown) was due for replacement, and was removed during a stent replacement procedure performed on (b)(6) 2015.According to the complainant, during the planned removal procedure, when they went to pull the stent out for replacement, they noticed that the stent had migrated up into the ureter.The stent was successfully removed using biopsy forceps.There were no reported issues with the device.The procedure was completed with another ascerta¿ 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 fine.
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Manufacturer Narrative
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Exact patient age unknown, but reported to be over 18 years of age.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 migration.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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Search Alerts/Recalls
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