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

Model Number	M00532810
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation result of cutting wire kinked.Block h11: investigation results the returned microknife xl was analyzed, and a visual inspection found that the transition and the wire at handle section were kinked, due these damages, the needle was not able to extend.The handle was found in good condition.No other problems with the device were noted.The results of the analysis performed on the returned device found that the transition wire was kinked.This condition could have occurred due to excess manipulation against this unit.It is most likely that as part of the device manipulation during the procedure an excess of force was applied to the device such as during the device insertion/removal through/from another device or by the interaction with the scope (hard surface), 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 kink the cutting wire at handle section making the needle unable to extend.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 a sphincterotomy procedure performed on (b)(6) 2025.During the procedure, there was no possibility of extending the needle.The handle was broken.The procedure was completed with another of the same device.There were no reported patient complications as a result after this event.This event has been deemed a reportable event based on the investigation finding of wire kinked.Please see block h11 for full investigation details.

• 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: 23364342
• Report Number: 3005099803-2025-05592
• Device Sequence Number: 12990789
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: (01)08714729172017(17)270226(10)35944890
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 0035944890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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