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

Model Number	M0063901050
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital (b)(6).Block h6: device code a0414 captures the reportable investigation results of sheath melted at the distal end.Block h11: investigation results.The returned zero tip basket device was analyzed, and a visual evaluation noted that the handle returned in good condition.It was also noted that the basket returned in its opened position.Microscopic examination was performed under magnification, and it was noticed that two basket wires were broken at the midpoint but was not fully detached.It was also noticed that the wires were kinked, and signs of melting were observed.Additionally, the sheath was found to be melted at the distal end.Functional examination was performed where the handle was actuated and the basket was able to open and close with no problem.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 stated that this device must not come in contact with any electrified instrument; however, the device had evidence of components melted.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 of 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.The observed findings of wires kinking 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.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 zero tip basket device was used during a transurethral renolithotripsy procedure.During procedure, the wire got damage in the basket section.The procedure was completed with this device and there were no patient complications reported as a result of this event.Analysis of the returned device revealed the sheath was found to be melted at the distal end.

• 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: 25191484
• Report Number: 2124215-2026-25949
• Device Sequence Number: 10333425
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)271117(10)37976326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/08/2026

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: 0037976326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2025
• 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 Sex: Unknown