Model Number M0061752620 |
Device Problems
Calcified (1077); Difficult to Remove (1528); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Sepsis (2067)
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Event Date 11/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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Block b3: date of event was approximated to (b)(6) 2023, based on the date the manufacturer became aware of the event.Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a040501 captures the reportable event of stent calcified.Imdrf patient code e0306 captures the reportable event of sepsis.
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Event Description
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It was reported to boston scientific corporation that a percuflex plus ureteral stent was successfully implanted during a procedure.The event date was unknown.During a planned stone removal, after three months of being implanted, it was noted that the stent was found encrusted and no longer visible.It was mentioned that the stent could not be grasped, so, they used a holmium laser to remove at least enough encrustation from the bladder loop and it took them four hours to remove the stent using a standard stainless-steel gripper.The procedure was successfully completed with a non-boston scientific device.A photo of the complaint device was provided and showed the stent was calcified.The patient suffered from sepsis and is now in the palliative department.
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Event Description
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It was reported to boston scientific corporation that a percuflex plus ureteral stent was successfully implanted during a procedure.The event date was unknown.During a planned stone removal, after three months of being implanted, it was noted that the stent was found encrusted and no longer visible.It was mentioned that the stent could not be grasped, so, they used a holmium laser to remove at least enough encrustation from the bladder loop and it took them four hours to remove the stent using a standard stainless-steel gripper.The procedure was successfully completed with a non-boston scientific device.A photo of the complaint device was provided and showed the stent was calcified.The patient suffered from sepsis and is now in the palliative department.Additional information received that the problem happened with a timespan within the last six months.
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Manufacturer Narrative
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Block b3: date of event was approximated to (b)(6) 2023, based on the date the manufacturer became aware of the event.Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a040501 captures the reportable event of stent calcified.Imdrf patient code e0306 captures the reportable event of sepsis.Update to block b5: additional information received on 01dec2023, that the problem happened with a timespan within the last six months.
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Search Alerts/Recalls
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