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

Model Number	M0063801000
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code f23 captures the reportable event of one end of the device became lodged and stuck in the patient's body requiring a second procedure to remove.
Event or Problem Description
It was reported to boston scientific corporation that a segura basket was used in the ureter during a cystoscopy/ureteroscopy procedure performed on (b)(6) 2022.During procedure, the device became lodged and stuck in the patient's body.A second procedure was required to remove the device on an unknown date.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 captures the reportable event of device difficult to remove.Imdrf device code a051104 captures the reportable event of basket failure to release stone.Impact code f2202 captures the event of second procedure was required to remove the device.Block b5 and h6 (device code) was updated based on additional information received on may 11, 2023.Block b1 and h6 (device code) has been corrected.
Event or Problem Description
It was reported to boston scientific corporation that a segura basket was used in the ureter during a cystoscopy/ureteroscopy procedure performed on (b)(6) 2022.During procedure, the device became lodged and stuck in the patient's body.A second procedure was required to remove the device on an unknown date.There were no patient complications as a result of this event.Additional information received on may 11, 2023.The stone was trapped in the anatomy and the basket was unable to be removed with the stone.The second procedure was endoscopy or ureteroscopy which was performed on (b)(6) 2022.

• 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: 16762645
• Report Number: 3005099803-2023-01879
• Device Sequence Number: 3034400
• Product Code: FFL
• UDI-Device Identifier: 08714729341864
• UDI-Public: 08714729341864
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2024
• Device Model Number: M0063801000
• Device Catalogue Number: 380-100
• Device Lot Number: 0027203951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: Black Or African American