MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063901040
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0401 captures the reportable investigation result of basket wire detached.Block h11: investigation results: the returned zero tip basket was analyzed, and a visual evaluation noted that the handle returned in good condition.It was also noted that the device returned with the basket on its open position.Media analysis was performed and shows that two basket wires was broken.Microscopic examination was performed under magnification, and it was noticed that that sheath was kinked.Additionally, two of the basket wires were broken then fully detached and melted which indicates the basket got in contact with an electric instrument.Functional examination was performed with the handle actuated and the basket was able to open and close.A labeling review was performed and found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.The ifu states that, this device must not come in contact with any electrified instrument; however, during the analysis it was found that two basket wires were broken and melted.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.With all the available information, boston scientific concludes that the reported event of basket kinked was confirmed.Based on the investigation results, it is possible to conclude that some operational factors, handling/manipulation, such as interaction with an electrified instrument and/or laser could cause the overheating of the basket wire resulting in the breakage.Additionally, the observed findings of the sheath kinked 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 kink the sheath.Taking all available information into consideration, the most probable cause of this complaint is failure to follow instructions since the main failure was traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported that a zero tip basket device was use during a ureteroscopic lithotripsy (ursl) procedure.Reportedly, they found that the basket was broken.The procedure was completed with another of the same device with no patient complications.However, investigation of the returned device revealed that two basket wires broke and fully detached from the basket.

• 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: 23905884
• Report Number: 2124215-2025-93361
• Device Sequence Number: 15943613
• Product Code: FFL
• UDI-Device Identifier: 08714729469636
• UDI-Public: (01)08714729469636
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/29/2025

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: M0063901040
• Device Catalogue Number: M0063901040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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