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	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: device code a0501 captures the reportable event of basket detachment.Block h11: investigation results the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made but the device has not yet been received by the manufacturer.However, media analysis was performed and showed that one zero tip basket with the sheath buckled accordioned.Additionally, the basket was not visible in the photos provided, therefore, it was not possible to confirm the reported event, and a physical evaluation of the device is required in order to verify and confirm the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on the available information, there is no evidence from the manufacturing review to indicate that the device malfunctioned due to a process-related defect since the device was not returned for analysis.There is no clear confirmation of the reported problem, as it is not possible to objectively determine whether the basket is not visible or if it is actually detached based solely on the image provided and without a proper physical evaluation of the device, the most probable cause of the reported issue cannot be established due to lack of objective evidence.The reported problem of sheath buckled could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could lead to buckled.Therefore, based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem since the investigation findings do not allow confirmation or exclusion of a device-related problem.
Event or Problem Description
It was reported that a zero tip basket device was used during a ureterolithotomy (tul) procedure.Post procedure, the front four claws and the entire basket detached.Reportedly, the detached basket did fall inside the patient.The procedure was completed with another of the same device with no patient complications.

• 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: 24562905
• Report Number: 2124215-2026-13249
• Device Sequence Number: 13117237
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)270311(10)36044153
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/10/2026

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: 0036044153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 03/11/2025
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 77 KG