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	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block 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 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 and one of the basket wires kinked.Media analysis was performed, and it showed that the blue heat shrink was separated from the luer lock; however, no detachment of the handle cannula was observed.Microscopic examination was performed under magnification, and it was possible to see that the blue heat shrink was separated from the luer lock.Additionally, one basket wire returned broken and not fully detached with evidence of use of an electrified instrument or laser.Functional examination was performed, and the handle was actuated.The basket was unable to close due to the observed detachment.A labeling review was performed and found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.The ifu states that, the device must not come in contact with any electrified instruments.However, it was noticed during analysis that the basket wire was melted indicating that it had contact with an electrified instrument.It is possible to conclude that some operational factors, handling/manipulation, such as interaction with an electrified instrument and/or laser that could cause the overheating of the basket wire resulting in the breakage.With all the available information, boston scientific concludes that the reported event was not confirmed since it was not possible to identify any evidence of the alleged issue on the device since the handle returned in good condition.Based on the investigation, the blue heat shrink detached from the luer lock that could consequently affect the functionality of closing the device.Additionally, it was noted that one of the basket wire kinked.These could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could lead to the observed damages.Furthermore, during manufacturing process, sheath assembly will undergo some of the inspections to ensure the integrity and functionality of the device and would have captured the failures found.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that a segura hemi basket was about to be used during a ureteroscopic lithotripsy (ursl) procedure.Reportedly, before the procedure, it was found that the basket handle component falls off.The procedure was completed with another of the same device with no patient complications.Analysis of the returned device revealed that one of the basket wires was broken.

• 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: 22449363
• Report Number: 2124215-2025-44861
• Device Sequence Number: 8597800
• 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): 07/08/2025

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
• Date Returned to Manufacturer: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/08/2025
• 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