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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
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 an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stricture performed on (b)(6) 2025.During the procedure, the cutting wire broke before advancing into the scope.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another microknife xl.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 cutting 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 inspection found that the cutting wire was kinked and broken at handle section.Destructive test was performed, the device was dissembled, and it was found that the hypotube was kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire break was confirmed.The results of the analysis performed on the returned device found that the hypotube was kinked, this condition could have occurred due to excess manipulation against this device.It is most likely that as part of the device manipulation during the procedure or preparation an excess of force was applied to the device such as during the device unpacking or by the interaction with a hard surface, the kink generate increased friction between the wire and the hypotube, causing the wire to become stuck or not be able to move easily, and with this friction the handle actuation leaded to break and kink in 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.
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 an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stricture performed on (b)(6) 2025.During the procedure, the cutting wire broke before advancing into the scope.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another microknife xl.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: 23228358
• Report Number: 3005099803-2025-05042
• Device Sequence Number: 21254227
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: (01)08714729172017(17)261008(10)35022377
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: M00532810
• Device Catalogue Number: M00532810
• Device Lot Number: 0035022377
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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