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	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a stone cone retrieval coil was about to be used during a ureteroscopic lithotripsy (ursl) procedure.Reportedly, 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.
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: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: device code a0401captures the reportable investigation results of basket wire break.Block h11: investigation results the returned segura hemi basket device was analyzed, and the handle returned in good condition.A visual evaluation noted that the device returned with the basket on its open position.It was also noted that the luer lock returned properly assembled on the luer connector.Microscopic examination was performed under magnification, and it was noticed that one of the basket wires was broken but was not fully detached.Functional examination was performed, and the basket was able to open and close.With the available information, boston scientific concludes that the reported event was not confirmed.Based on the analysis results, it was not possible to identify any evidence of the alleged issue on the device since the handle returned in good condition and also the luer lock returned properly assembled on the luer connector.Additionally, the evidence from the product record review did not identify a potential product quality issue.The reported issues 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 one of the basket wires.Additionally, the manufacturing process ensure the integrity and functionality of the device and would have captured if one of the basket wires were broken.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.

• 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: 21713618
• Report Number: 2124215-2025-19064
• Device Sequence Number: 10071615
• Product Code: FFL
• UDI-Device Identifier: 08714729341949
• UDI-Public: 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): 03/27/2025

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: 02/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/27/2025
• 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