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

Model Number	4584
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of needle knife break.Imdrf patient code e2008 captures the reportable event of unretrievable device fragment.
Event or Problem Description
It was reported to boston scientific corporation that an rx needle knife xl was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when the needle knife was inside the patient and the physician was performing a cut, after the first cut the needle was bend.The physician then asks to put the needle back however the knife snapped and fell in the patient's ampulla.It was reported that the physician was able to move the needle fragment away from the ampulla and believed it was dropped in the duodenum.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21773620
• Report Number: 3005099803-2025-01425
• Device Sequence Number: 20883019
• Product Code: KNS
• UDI-Device Identifier: 08714729283799
• UDI-Public: (01)08714729283799(17)261107(10)35241113
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4584
• Device Catalogue Number: 4584
• Device Lot Number: 0035241113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2025
• Initial Report FDA Received Date: 04/04/2025
• Date Device Manufactured: 11/07/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown