MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00545170
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable investigation results of cutting wire kinked.Block h11: investigation results the returned autotome rx 44 was analyzed; a visual examination found that the cutting wire was kinked.Additionally, the working length was twisted, bent and kinked at distal section.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 kinked.Additionally, the working length was twisted, bent and kinked at distal section, and the catheter was incorrectly oriented due to the twisted section on the working length.These conditions could have been generated as part of the device manipulation during preparation an excess of force was applied in order to get the device out of the package or during mandrel removal, the twisted section in the working length caused the catheter to be disoriented.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.
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2026.During the preparation outside the patient, it was reported that the tome was bent and the insertion direction was incorrect.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed a reportable event based on the investigation results: the cutting wire kinked.Please refer to block h11 for full investigation details.

• Brand Name: AUTOTOME RX 44
• 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: 24731830
• Report Number: 3005099803-2026-01142
• Device Sequence Number: 15756838
• Product Code: KNS
• UDI-Device Identifier: 08714729444749
• UDI-Public: (01)08714729444749(17)280510(10)36489457
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013153
• 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): 03/30/2026

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: M00545170
• Device Catalogue Number: M00545170
• Device Lot Number: 0036489457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• 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: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2025
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 56 KG