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); Mechanical Problem (1384); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2025.During the procedure, the physician attempted to perform a precut using a needle knife.Although the needle knife was inserted through the scope, the needle failed to extend from the device.The procedure was subsequently completed using a different device.There were no patient complications reported due to this event and the patient's condition at the conclusion of the procedure was reported to be good.Note: this event has been deemed a reportable event based on the investigation results: the cutting wire broke and cutting wire kinked.Please refer to block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of cutting wire broken.Imdrf device code a040601 captures the reportable investigation results of cutting wire kinked.Block h11: investigation results the returned microknife xl was analyzed; a visual examination found that the cutting wire was broken and kinked at the handle.The device was dissembled and it was found that the hypo tube and the wire were kinked.No other problems with the device were noted.With all the available information, the product analysis of the returned device revealed that the cutting wire was broken and kinked at the handle.Additionally, the hypo tube and the wire was kinked.The hypo tube and the wire kinked could have occurred due to excess manipulation against the 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 or removal through or from another device or by the interaction with the scope (hard surface), the kink generate increased friction between the wire and the hypo tube, 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, making the needle unable to extend.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.

• 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: 24758871
• Report Number: 3005099803-2026-01186
• Device Sequence Number: 8707742
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: (01)08714729172017(17)260605(10)34178762
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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 Expiration Date: 06/05/2026
• Device Model Number: M00532810
• Device Catalogue Number: M00532810
• Device Lot Number: 0034178762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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