Model Number 175-252 |
Device Problem
Break (1069)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device code (b)(4) captures the reportable event of stent shaft broken.Conclusion code(b)(4) is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure in the ureter performed on (b)(6)2022.During the procedure, when the pusher was placed, the coil was positioned in the left ureter and in the right ureter it was crowded and neither the guide nor the pusher advanced, much less the fractionated catheter, the ureter of the patient with evidence of bleeding was removed with difficulty.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Update to block e1: initial reporter's name: dr.(b)(6).Initial reporter's phone number: (b)(6).
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Event Description
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It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure in the ureter performed on (b)(6) 2022.During the procedure, when the pusher was placed, the coil was positioned in the left ureter and in the right ureter it was crowded and neither the guide nor the pusher advanced, much less the fractionated catheter, the ureter of the patient with evidence of bleeding was removed with difficulty.There were no patient complications reported as a result of this event.Additional information received that the patent is stable with reversible injury.
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Event Description
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It was reported that a percuflex plus ureteral stent was used during a ureteral lithiasis procedure in the ureter performed on (b)(6) 2022.During the procedure, when the pusher was placed, the coil was positioned in the left ureter and in the right ureter it was crowded and neither the guide nor the pusher advanced, much less the fractionated catheter, the ureter of the patient with evidence of bleeding was removed with difficulty.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 with reversible injury.
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Manufacturer Narrative
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Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Block h11: block b5 has been updated with procedure name.
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Search Alerts/Recalls
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