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

Model Number	M0063801120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a segura hemi basket device was about to be used during a ureteroscopic lithotripsy (ursl) procedure.During preparation, it was found that the basket can't be worked.Additionally, it was noticed that one of the basket wires got detached.The procedure was completed with another of the same device with no patient complications.
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 unique identifier (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 event of basket wire break.
Event or Problem Description
It was reported that a segura hemi basket device was about to be used during a ureteroscopic lithotripsy (ursl) procedure.During preparation, it was found that the basket can't be worked.Additionally, it was noticed that one of the basket wires got detached.The procedure was completed with another of the same device with no patient complications.
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 unique identifier (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 event of basket wire break.Block h11: investigation results the returned segura hemi basket was analyzed, and a visual evaluation noted that the handle returned in good condition.It was also noted that the device returned with the basket on its open position.Media analysis was performed, and it shows that one of the basket wires broken but not fully detached.Microscopic examination was performed under magnification, and it was possible to see that one of the basket wires was broken.Functional examination was performed, and the handle was actuated then the basket was able to open and close.With all the available information, boston scientific concludes that the reported event was confirmed.This could be related to handling and manipulation of the device during preparation; it is probable that an excess of force applied to the device such as operational factors could lead to break the basket wire.Taking all available information into consideration, an investigation conclusion code of adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.

• 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: 21986451
• Report Number: 2124215-2025-29048
• Device Sequence Number: 20908558
• 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,Followup
• Report Date (Section B): 07/10/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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