MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Zero Tip; Dislodger, Stone, Basket, Ureteral, Metal

Model Number	M0063901050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event was approximated to 06/01/2026 based on the date the manufacturer became aware of the event.Block h6: device code a0401 captures the reportable event of basket wire detachment.Impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that a zero tip basket device was used during a procedure, reportedly, when the basket was used to retrieve the stone fragment, the tip broke inside the patient.The physician was using the basket with a laser and there were no pieces of fragment was left inside the patient.No further information has been obtained despite good faith efforts.

• Brand Name: Zero Tip
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25755185
• Report Number: 2124215-2026-36658
• Device Sequence Number: 10532085
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)280207(10)38545735
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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 Model Number: M0063901050
• Device Catalogue Number: M0063901050
• Device Lot Number: 0038545735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 02/07/2026
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 191 LB
• Patient Race: White