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

Model Number	M0063303040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Foreign Body In Patient (2687)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a mini gemini basket was used in the left ureter during a cystoscopy, ureteroscopy, laser lithotripsy and stone extraction procedure performed on (b)(6) 2023 during the procedure, the basket wires broke in the left ureter around ureteral stone.It was reported that two fragments of wire from basket remained in the left ureter.Additionally, the physician attempted to remove retained pieces of basket with piranha grasping forceps but unsuccessful.The procedure was completed with another mini gemini basket.The patient experienced narrowing of ureter with modest hydroureter above, pyelonephritis.
Additional Manufacturer Narrative
Block a2: patient's exact weight is (b)(6).Block g2: medwatch # mw5116628 block h6: imdrf patient code e2008 captures the reportable patient event of foreign body inside the patient.Imdrf patient code e1310 captures the reportable patient event of urinary tract infection.Block h6: medical device code a0401 captures the reportable event basket wire break.

• Brand Name: GEMINI
• 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: 17822272
• Report Number: 3005099803-2023-05125
• Device Sequence Number: 11372737
• Product Code: FFL
• UDI-Device Identifier: 08714729074281
• UDI-Public: 08714729074281
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2023

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: 06/26/2025
• Device Model Number: M0063303040
• Device Catalogue Number: 330-304
• Device Lot Number: 0029660262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White