MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC PAIRED WIRE HELICAL STONE RETRIEVAL BASKET (GEMINI 3); DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063303040

Patient Problem Foreign Body In Patient (2687)

Event Date 08/04/2023

Event Type  Injury  

Event Description

Physician attempted to use gemini 3 wire basket (ref m0063303040, lot 29660262, exp 06-26-2025) to extract left ureteral stone.During extraction, basket wires broke in left ureter around ureteral stone.Two fragments of wire from basket remained in left ureter.Physician's attempts to remove retained pieces of basket with pirahna grasping forceps unsuccessful x2.

• Brand Name: BOSTON SCIENTIFIC PAIRED WIRE HELICAL STONE RETRIEVAL BASKET (GEMINI 3)
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 17498757
• MDR Text Key: 320912682
• Report Number: MW5122870
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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: 330304
• Device Lot Number: 29660262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White