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Model Number M0061453520 |
Device Problems
Unsealed Device Packaging (1444); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block e1: initial reporter address:(b)(6) block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.
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Event Description
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It was reported to boston scientific corporation that a percuflex ureteral stent was used during a ureteral calculus procedure in the ureter performed on (b)(6), 2023.During preparation, when the device was unpacked, the package was found to be damaged and at risk of not being sterile.The procedure was successfully completed with another percuflex ureteral 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 stable.A photo of the complaint device was provided and showed that the stent was in the packaging kinked.
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Manufacturer Narrative
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Initial reporter address: (b)(6).Imdrf device code a020503 captures the reportable event of packaging seal compromised.The returned percuflex ureteral was analyzed, and a visual and media evaluation noted that there's no visual damages found.In the pouch, remaining adhesive of the seals in the places were found.The box was returned opened and damaged with evidence of excessive manipulation.Additionally, the suture and positioner were returned.During magnification, the positioner was bent, and the suture was loaded and uncut.No other problems with the device were noted.The reported event of stent kinked was not confirmed.Taking all available information into consideration, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.The problem could be related with an excess of handling and manipulation in the preparation of the device leading the positioner to be bent.Therefore, the as analyzed code for both issues will be adverse event related to procedure.For the reported problem of stent kinked, it is not confirmed since stent kinked was not detected during the analysis.For this reason, the as analyze code will be no problem detected.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.
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Event Description
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It was reported to boston scientific corporation that a percuflex ureteral stent was used during a ureteral calculus procedure in the ureter performed on (b)(6), 2023.During preparation, when the device was unpacked, the package was found to be damaged and at risk of not being sterile.The procedure was successfully completed with another percuflex ureteral 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 stable.A photo of the complaint device was provided and showed that the stent was in the packaging kinked.
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Search Alerts/Recalls
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