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

Model Number M0063303040

Device Problem Break (1069)

Patient Problems Urinary Tract Infection (2120); Foreign Body In Patient (2687)

Event Date 08/04/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 324319344
• Report Number: 3005099803-2023-05125
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729074281
• UDI-Public: 08714729074281
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White