MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MICROKNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00532810
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was attempted to be used in the bile duct during a sphincterotomy procedure to treat stones in the bile ducts performed on (b)(6) 2025.During preparation, after opening the package and testing the needle ejection, it was noticed that it is not possible.A broken wire in the handle was found.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: (investigation results) the returned microknife xl was analyzed, and a visual evaluation noted that the cutting wire was kinked and broken at handle section.The device was dissembled, and it was found that the hypotube was kinked near to the transition.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was confirmed.Upon analysis, it was found that the transition was kinked and broken at the handle section.This condition could have occurred due to excess manipulation against this unit.It is most likely that as part of the device manipulation, possibly during preparation an excess of force was applied to the device such as during its unpacking, by the interaction with a hard surface or during handle actuation, the kink generate increased friction between the wire and the transition, causing the wire to become stuck or not be able to move easily, and with this friction the handle actuation leaded to break the cutting wire at handle section.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was attempted to be used in the bile duct during a sphincterotomy procedure to treat stones in the bile ducts performed on (b)(6) 2025.During preparation, after opening the package and testing the needle ejection, it was noticed that it is not possible.A broken wire in the handle was found.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: MICROKNIFE XL
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23118761
• Report Number: 3005099803-2025-04770
• Device Sequence Number: 21142987
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: (01)08714729172017(17)260506(10)33973900
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K973826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Expiration Date: 05/06/2026
• Device Model Number: M00532810
• Device Catalogue Number: M00532810
• Device Lot Number: 0033973900
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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