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	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a zero tip basket device was used during a procedure.Reportedly, the wire was damaged and separated from the basket section.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of basket wire detachment.
Event or Problem Description
It was reported that a zero tip basket device was used during a procedure.Reportedly, the wire was damaged and separated from the basket section.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Investigation results: the returned zero tip basket was analyzed, and a visual evaluation noted that the handle returned in good conditions.It was also noted that the basket returned in its opened position.Microscopic examination was performed under magnification, and it was noticed that one of the basket wires broken from the tip but was not fully detached.Additionally, necking evidence was found on the broken wire.Functional examination was performed with the handle actuated, and the basket was able to open and close.With all the available information, boston scientific concludes that the reported event was confirmed.During the analysis, a comprehensive investigation into the reported problem of the zero tip basket's knot, including simulation, raw material, and assembly testing, the root cause remains undetermined.It suggests that variations in knot diameter and potential inconsistencies in the knotting process may contribute to the problem, but these factors alone do not conclusively explain the issue.Device history record review was completed and 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 wire broken was defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on review of reported information and investigation results, an investigation conclusion code of unable to exclude device problem was assigned to this investigation.

• 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: 24264158
• Report Number: 2124215-2026-06513
• Device Sequence Number: 15957785
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)270912(10)37444243
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 0037444243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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