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

Model Number	M00532810
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); 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	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of a wire kinked.
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 performed on (b)(6) 2026.During the procedure, after passing the device through the endoscope channel and making the incision, it was not possible to reassemble the needle.The endoscope was removed from the patient with the device before the device was removed from the endoscope.A photo was provided by the customer and showed that the needle was extended and kinked, and the tip of the extrusion was split.It was reported that no part of the device was detached and fell into the patient.The procedure was completed with the another of the same device.There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of a wire kinked.Block h11: investigations results the returned microknife xl was analyzed, visual and microscopic inspection found that the cutting wire was kinked and tip damaged.Also, the paint marker at the tip was peeled.A media analysis was performed on the photo provided by the complainant.The photo revealed that the device inside its opened and labeled pouch with the cutting wire kinked and broken.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire kinked was confirmed.According to the product analysis performed on the device, the cutting wire was kinked and the paint at the tip was peeled, these problems could be caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.Once the cutting wire was kinked, any attempt to retract the needle can damage the tip.Based on all gathered information and the analysis performed, the most probable 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.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of wire kinked was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.
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 performed on (b)(6) 2026.During the procedure, after passing the device through the endoscope channel and making the incision, it was not possible to reassemble the needle.The endoscope was removed from the patient with the device before the device was removed from the endoscope.A photo was provided by the customer and showed that the needle was extended and kinked, and the tip of the extrusion was split.It was reported that no part of the device was detached and fell into the patient.The procedure was completed with the another of the same device.There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.

• 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: 24490071
• Report Number: 3005099803-2026-00778
• Device Sequence Number: 4980023
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: (01)08714729172017(17)271024(10)37789275
• 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,Followup
• Report Date (Section B): 04/15/2026

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: M00532810
• Device Catalogue Number: M00532810
• Device Lot Number: 0037789275
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2025
• 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