Model Number M0061752630 |
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
Unspecified Infection (1930)
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Event Date 11/01/2023 |
Event Type
Injury
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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 in the urogenital tract.The event date was unknown.During a planned stent removal, after three months of being implanted, it was noted that the stent had high encrustation rate and light stones.It was mentioned that they require laser lithotripsy procedure, and it took them four hours to remove the stent using a standard stainless-steel gripper under general anesthesia.The procedure was successfully completed with a non-boston scientific device.The patient experienced infection and was given a medication of antibiotic drugs.
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Manufacturer Narrative
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Block b3: date of event was approximated to november 1, 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 e1906 captures the reportable event of infection.
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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 in the urogenital tract.The event date was unknown.During a planned stent removal, after three months of being implanted, it was noted that the stent had high encrustation rate and light stones.It was mentioned that they require laser lithotripsy procedure, and it took them four hours to remove the stent using a standard stainless-steel gripper under general anesthesia.The procedure was successfully completed with a non-boston scientific device.The patient experienced infection and was given a medication of antibiotic drugs.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: (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 e1906 captures the reportable event of infection.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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