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	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a ureterolithotomy procedure a zero tip basket was intended to be used, it was found that front four claws were detached, however, it did not fall inside the patient.The procedure was completed using another of the same device.No patient complications were reported.
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 preparation of a ureterolithotomy procedure, a zero tip basket was intended to be used, it was found that front four claws were detached but it did not fall inside the patient.The procedure was completed using another device of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of basket detachment.Correction to b5: describe event or problem.Block h11: the returned zero tip basket was analyzed.During the inspection it was found that the handle returned in good conditions and the basket was not visible in the device.Additionally, media review performed on the provided picture indicates that the basket was not visible on the device.However, after removing the sheath, it was determined that the basket was not detached but instead retained within the sheath.The device was further examined under magnification, confirming that the basket was properly bonded to the device, with no evidence of detachment, separation, or bond failure observed.The device was actuated before removing the sheath and the basket was not coming off the sheath.A dimensional test was performed in order to discard that the interaction between the components was generating the failure to open.The reported event of basket detachment could not be confirmed based on investigation results.Review of the device history record (dhr) was confirmed that the 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 opening failed 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.Based on the investigation results, complaint was assigned with an investigation conclusion code of cause linked to device but unable to trace more specifically since the investigation findings do not lead to a clear conclusion about the cause of the basket being not visible on the device.

• 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: 24379308
• Report Number: 2124215-2026-09126
• Device Sequence Number: 10279671
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)270513(10)36508581
• 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): 04/21/2026

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: 0036508581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 71 KG