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

Model Number	M0063901050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of basket detachment.
Event or Problem Description
It was reported that during ureterolithotomy procedure, a zero tip basket was used, and it was found that the whole basket fell off outside of the patient.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that during ureterolithotomy procedure, a zero tip basket was used, and it was found that the whole basket fell off outside of the patient.The procedure was completed with another of the same device.No patient complications were report.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of basket detachment.The device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device, however response was not received.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of "basket detachment of device or device component" was defined in the risk documentation and is documented accordingly in the prr.A review of the manufacturing records was performed and no issues that could have contributed to this event were found.Furthermore, the review of the manufacturing records did not identify any failure of the product to meet its material, assembly, or performance specifications.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 25751066
• Report Number: 2124215-2026-36601
• Device Sequence Number: 10147699
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)270929(10)37577757
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0063901050
• Device Catalogue Number: M0063901050
• Device Lot Number: 0037577757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 09/29/2025
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 173 LB