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

Model Number	M0063901050
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.
Event or Problem Description
It was reported that during procedure a zero tip was used.It was found that the wire was damaged and was separated and detached from the basket.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.Block h11: the returned zero tip device was analyzed.During product analysis it was found one of the basket wires broken from the tip but not fully detached.The device was evaluated under magnification, and it was possible to see that one of the basket wires broken from the tip (not fully detached).Necking evidence was visible not being able to confirm the reported issue of basket detachment of device or device component since no detachment of the basket was detected.Additionally, the reported defect of basket detachment of device or device component is classified under the investigation conclusion code no problem detected, since after the tests performed on the returned device, it was not possible to identify this failure mode.A review of the device history record (dhr) 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 events of basket detachment of device or device component and basket wire broken were defined in the risk documentation and is documented accordingly.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.
Event or Problem Description
It was reported that during procedure a zero tip was used.It was found that the wire was damaged and was separated and detached from the basket.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 24872666
• Report Number: 2124215-2026-20034
• Device Sequence Number: 9878068
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)271117(10)37976326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 06/05/2026

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: 0037976326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2025
• 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 Sex: Unknown