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

Model Number	M0063801060
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401 is being used to capture the reportable event of the basket had a detached strand the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.
Event or Problem Description
It was reported to boston scientific corporation that a segura basket hemi basket was used on an unknown date.It was reported that the basket had a detached strand before use.A photo provided by the customer shows that the basket wire was still attached to one end.There was no patient complication reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a segura basket hemi basket was used on an unknown date.It was reported that the basket had a detached strand before use.A photo provided by the customer shows that the basket wire was still attached to one end.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 is being used to capture the reportable event of the basket had a detached strand block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h10: the returned segura basket was analyzed, and a visual evaluation noted that device was returned with the basket open and the basket wire break.The customer provided a photo of the basket in an open state, but it is likely that one of the four wires broke.Functional test found the segura basket was able to open but could not completely close due to the due to the found issue.The reported event was confirmed.Based on all available information, it is probable that operational factors such as (handling / manipulation, interaction with other devices, excess force applied during use in preparation) caused this failure and, as a result, affected the device's performance.Additionally, this failure led to the device could not close completely.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16662638
• Report Number: 3005099803-2023-01718
• Device Sequence Number: 5934195
• Product Code: FFL
• UDI-Device Identifier: 08714729341901
• UDI-Public: 08714729341901
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 10/17/2025
• Device Model Number: M0063801060
• Device Catalogue Number: 380-106
• Device Lot Number: 0030365271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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