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

Model Number	M0063801060
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a segura hemi basket device was used during procedure.During the procedure, the segura basket became distorted while grasping the ureteral stones.The procedure was completed with another of the same device and with no patient complications.Analysis of the returned basket revealed that two basket wires were broken.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 06/01/2024 based on the date the manufacturer became aware of the event.Block h6: device code a0401 captures the reportable investigation result of basket wire break.Block h11: investigation results the returned segura hemi basket device was analyzed, and a visual evaluation noted that the device returned with the basket on its close position and the handle returned in good conditions.Microscopic examination was performed, and it was noticed that two basket wires were broken.There was evidence that the broken wires were melted indicating that they got in contact with an electrified instrument.Additionally, the sheath was found bent/kinked at the proximal and distal section.The sheath was also found detached/separated at the distal section and the basket was bent/kinked.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, this device must not come in contact with any electrified instrument; however, during the analysis there was evidence that the basket wires were melted.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.With all the available information, boston scientific concludes that the reported event of basket kinked was confirmed.Based on the investigation results it is probable that an excess of force applied to the device such as operational factors during their use could cause these adverse events.Additionally, it is also possible to conclude that some operational factors, handling/manipulation, such as interaction with an electrified instrument and/or laser could cause the overheating of the basket wires resulting in the breakage that could be related with the reported allegation.Taking all available information into consideration, the most probable cause of this complaint is failure to follow instructions since the main observation was traced to the user not following the manufacturer's instructions.

• 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: 20678867
• Report Number: 2124215-2024-70742
• Device Sequence Number: 20964651
• Product Code: FFL
• UDI-Device Identifier: 08714729341901
• UDI-Public: 08714729341901
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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 Model Number: M0063801060
• Device Catalogue Number: 380-106
• Device Lot Number: 0033498176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2024
• 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