MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063801120
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a segura hemi basket was set to be used during a ureteroscopic lithotripsy (ursl) procedure.Reportedly, before the surgery, it was found that the basket handle component fell off.The procedure was completed with another of the same device and there were no patient complications reported as a result of this event.Analysis of the returned device revealed that one of the basket wires was broken.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0401 captures the reportable investigation result of basket wire broken.Block h11: investigation results the returned segura hemi basket was analyzed, and it was noted that one basket wire was broken and kinked.Additionally, the sheath was torn.Functional examination was performed with the handle actuated, and the basket was able to open and close with no problem.With all the available information, boston scientific concludes that the reported event was not confirmed since no handle related damages were found and no evidence of the originally reported problem was identified.However, additional conditions were identified on the returned device, these findings could be related to handling and manipulation of the device during preparation or use.It is probable that an excess of force applied to the device or other operational factors during the procedure could have led to these conditions.Based on analysis results, an investigation conclusion code of device problem excluded was assigned to this investigation.

• Brand Name: SEGURA HEMISPHERE
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24299742
• Report Number: 2124215-2026-07280
• Device Sequence Number: 13315301
• Product Code: FFL
• UDI-Device Identifier: 08714729341949
• UDI-Public: (01)08714729341949
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0063801120
• Device Catalogue Number: 380-112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown