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

Model Number	M0063801060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name:(b)(6) hospital.Block h6: imdrf code a0401 captures the reportable event of a basket wire break.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemi basket was used in the ureter during a ureteroscopic lithotripsy (ursl) procedure performed on (b)(6) 2024.During the procedure, when the physician attempted to remove the stone, one of the wires in the basket was broken; however, the broken wire was still connected to the end of the basket.The procedure was completed with another segura hemi basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: hsinchu national taiwan university branch biomedical hospital zhubei campus block h6: imdrf code a0401 captures the reportable event of a basket wire break.Block h10: the returned segura hemi basket was analyzed, and a visual evaluation noted the basket was in its close position.Visual and microscopic inspection identified that one of the basket wires was broken but not fully detached.Additionally, there was evidence that the basket wire was melted.During the functional inspection, the handle was actuated, and the basket was able to open and close.Therefore, the reported failure of "basket wire break" is confirmed.Based on the most relevant information, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible to conclude that some operational factors such as handling/manipulation, interaction with an electrified instrument and/or laser could cause the overheating of the basket wire resulting in the breakage.The instructions for use indicates that the device must not come in contact with any electrified instrument.Based on the analysis results, the most probable cause is "failure to follow instructions" since the failure reported was traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported that a segura hemi basket was used in the ureter during a ureteroscopic lithotripsy (ursl) procedure performed on (b)(6) 2024.During the procedure, when the physician attempted to remove the stone, one of the wires in the basket was broken; however, the broken wire was still connected to the end of the basket.The procedure was completed with another segura hemi basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 18932826
• Report Number: 2124215-2024-16209
• Device Sequence Number: 9445990
• Product Code: FFL
• UDI-Device Identifier: 08714729341901
• UDI-Public: 08714729341901
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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 Expiration Date: 07/18/2026
• Device Model Number: M0063801060
• Device Catalogue Number: 380-106
• Device Lot Number: 0032044712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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