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	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: the first affiliated (b)(6) hospital.Block h6: device code a0401 captures the reportable event of basket wire detached.
Event or Problem Description
It was reported that a zero tip basket device was set to be used during a kidney stone removal procedure.Reportedly, after unpacking it was found that one of the basket wires completely fell off from the basket.The procedure was completed with another of the same device with no patient complications.
Event or Problem Description
It was reported that a zero tip basket device was set to be used during a kidney stone removal procedure.Reportedly, after unpacking it was found that one of the basket wires completely fell off from the basket.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
(b)(6).Device code a0401 captures the reportable event of basket wire detached.Investigation results: the returned zero tip basket was analyzed, and a visual evaluation was noted that the handle returned in good condition.It was also noted that the basket returned in its open position.Microscopic examination was performed under magnification, and it was possible to noticed that one of the basket wires broken and fully detached.Additionally, necking evidence was visible on the broken wire.Functional examination was performed with the handle actuated, and the basket was able to open and close with no issues.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.With all the available information, boston scientific concludes that the reported event 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.

• 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: 24088620
• Report Number: 2124215-2026-03103
• Device Sequence Number: 15874168
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)270217(10)35870622
• 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,Followup
• Report Date (Section B): 05/12/2026

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: 0035870622
• 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: 12/21/2025
• Supplement Date Received by Manufacturer: 02/25/2026; 04/22/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/19/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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 Age: 43 YR
• Patient Sex: Male
• Patient Weight: 76 KG