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

Model Number	M0063901050
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a020504 captures the reportable event of hole in sterile packaging.
Event or Problem Description
It was reported that a zero tip basket device was set to be use during a procedure.During unpacking, a hole was found in the sterile packaging.There were no procedure and patient involved.
Event or Problem Description
It was reported that a zero tip basket device was set to be use during a procedure.During unpacking, a hole was found in the sterile packaging.There were no procedure and patient involved.
Additional Manufacturer Narrative
Block h6: device code a020504 captures the reportable event of hole in sterile packaging.Block h11: investigation results.The returned zero tip basket with closed pouch was analyzed, and it was noted that a hole was in the plastic side of the pouch.With all the information available, boston scientific concludes that the reported event of packaging tear, rip or hole in device packaging 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.Additionally, there is a process to verify the integrity of the seal on products in the unrestricted area.The products also undergo a verification process involving a cosmetic inspection, and any damage during collection will be reported.This means that only products without problems will be packed in a shipping box.This process guarantees the integrity of the pouch and would have detected the fault found.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: 23671867
• Report Number: 2124215-2025-86825
• Device Sequence Number: 9708220
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)270830(10)37333984
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 0037333984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2025
• 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