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

Model Number	M00532810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
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 of vater during a cholangiography procedure performed on (b)(6) 2025.During the procedure, the device was used to make a cut in the papilla of vater and there was no problem encountered.The physician requested to keep the tip of the cutting needle to further examine the papilla.As the physician ask to use the device again, the device showed resistance when trying to retract the tip.After several attempts and due to the force applied, the deployment system was damaged, and the tip of the needle never came out.It was reported that the pull wire at the handle of the microknife xl broke.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 wire broken.
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was used in the papilla of vater during a cholangiography procedure performed on (b)(6) 2025.During the procedure, the device was used to make a cut in the papilla of vater and there was no problem encountered.The physician requested to keep the tip of the cutting needle to further examine the papilla.As the physician ask to use the device again, the device showed resistance when trying to retract the tip.After several attempts and due to the force applied, the deployment system was damaged, and the tip of the needle never came out.It was reported that the pull wire at the handle of the microknife xl broke.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 wire broken.Block h11: (investigation result): the returned microknife xl was analyzed, and a visual and microscopic evaluation noted that the cutting wire was blackened and broken.No other problems with the device were noted.The reported event of wire break was confirmed.Upon analysis, it was found that the cutting wire was blackened and broken.The blackened wire indicates that a current was applied to the device.Based on the condition of the device, the wire break could have been generated by the technique used, the patient anatomy, interaction with the scope or additional devices.Also, if the maximum voltage exceeded or if the cutting wire was not in constant motion.These procedural factors could have contributed to the broken wire leading to an extension problem due to the missing broken section.Based on all gathered information, the most probable root cause is adverse event related to procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21454154
• Report Number: 3005099803-2025-00621
• Device Sequence Number: 7320490
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: (01)08714729172017(17)260312(10)33612993
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 05/12/2025

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: 03/12/2026
• Device Model Number: M00532810
• Device Catalogue Number: M00532810
• Device Lot Number: 0033612993
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Weight: 100 KG