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

Model Number	M00545840
Medical Device Problem Codes	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	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of wire kink.
Event or Problem Description
It was reported to boston scientific corporation that an rx needle knife xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat strictures performed on (b)(6) 2025.During the procedure, the needle bent.The procedure was completed with another rx needle knife xl.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an rx needle knife xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat strictures performed on (b)(6) 2025.During the procedure, the needle bent.The procedure was completed with another rx needle knife xl.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of wire kink.Block h11: investigation results the returned rx needle knife xl was analyzed, and a visual inspection found that the cutting wire was kinked, also, the working length was bent.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire kinked was confirmed.The results of the analysis performed on the returned device found that the working length was bent and the cutting wire was kinked.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.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.

• Brand Name: RX NEEDLE KNIFE 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: 23632173
• Report Number: 3005099803-2025-06311
• Device Sequence Number: 10314853
• Product Code: KNS
• UDI-Device Identifier: 08714729283799
• UDI-Public: (01)08714729283799(17)270522(10)36587825
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/08/2026

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: M00545840
• Device Catalogue Number: M00545840
• Device Lot Number: 0036587825
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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