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	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of basket detachment.
Event or Problem Description
It was reported that a zero tip basket device was set to be used during a ureteral calculi procedure.During preparation, it was found that one end of the basket was fractured.It was further clarified that the entire basket was detached.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of basket detachment.Block h11: investigation results the returned zero tip basket was analyzed, and it was noted that the handle appears in good condition and the basket does not return for analysis.Microscopic examination was performed under magnification, and it was noticed that the basket was detached from the notch cannula.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.With all the available information, boston scientific concludes that the reported event of was confirmed.Based on the analysis results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.However, the investigation findings did not lead to a clear conclusion about the cause of this problem.Additionally, the manufacturing process, includes different inspections to ensure that all finished devices meet specifications.Since the device was received already open, it is not possible to determine if the failure was caused due to incorrect use of the product.All the information gathered demonstrates that the cause of the event was not manufacturing related.Taking all available information into consideration an investigation conclusion code of cause linked to device but unable to trace more specifically was assigned to this investigation since the findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
It was reported that a zero tip basket device was set to be used during a ureteral calculi procedure.During preparation, it was found that one end of the basket was fractured.It was further clarified that the entire basket was detached.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: 23617023
• Report Number: 2124215-2025-85178
• Device Sequence Number: 15695336
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)260822(10)34697446
• 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,Followup
• Report Date (Section B): 02/10/2026

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 Expiration Date: 08/22/2026
• Device Model Number: M0063901050
• Device Catalogue Number: M0063901050
• Device Lot Number: 0034697446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 69 KG