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Model Number M0061457490 |
Device Problems
Entrapment of Device (1212); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2023 |
Event Type
Injury
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Event Description
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It was reported to boston scientific that a percuflex plus ureteral stent was used during stone removal procedure in the kidney, performed on (b)(6) 2023.On (b)(6) 2023, a second procedure to remove stones was performed.During this procedure, it was noticed that the upper coil of the implanted stent was not completely coiled in the pelvis.The physician had difficulty in getting the guidewire through implanted stent to remove the stent and kidney stones.The stent was successfully removed without difficulty and a new percuflex plus ureteral stent was implanted and successfully completed the procedure.There were no patient complications reported as a result of this event.
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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 a04 captures the reportable event of coil, coil memory during stent removal.
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Search Alerts/Recalls
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