Model Number M0063801000 |
Device Problems
Difficult to Remove (1528); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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Block h6: imdrf device code f23 captures the reportable event of one end of the device became lodged and stuck in the patient's body requiring a second procedure to remove.
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Event Description
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It was reported to boston scientific corporation that a segura basket was used in the ureter during a cystoscopy/ureteroscopy procedure performed on (b)(6) 2022.During procedure, the device became lodged and stuck in the patient's body.A second procedure was required to remove the device on an unknown date.There were no patient complications as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a150207 captures the reportable event of device difficult to remove.Imdrf device code a051104 captures the reportable event of basket failure to release stone.Impact code f2202 captures the event of second procedure was required to remove the device.Block b5 and h6 (device code) was updated based on additional information received on may 11, 2023.Block b1 and h6 (device code) has been corrected.
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Event Description
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It was reported to boston scientific corporation that a segura basket was used in the ureter during a cystoscopy/ureteroscopy procedure performed on (b)(6) 2022.During procedure, the device became lodged and stuck in the patient's body.A second procedure was required to remove the device on an unknown date.There were no patient complications as a result of this event.Additional information received on may 11, 2023.The stone was trapped in the anatomy and the basket was unable to be removed with the stone.The second procedure was endoscopy or ureteroscopy which was performed on (b)(6) 2022.
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Search Alerts/Recalls
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