MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Autotome RX 44; Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Model Number	M00545170
Medical Device Problem Codes	Failure to Align (2522); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 44 was attempted to be used in the intestinal tract during an endoscopic retrograde cholangiopancreatography (ercp) with stone removal procedure to treat transduodenal oddi's sphincteroplasty performed on (b)(6) 2026.During the procedure, when bowing, the plastic sheath at the autotome tip was kinked.As a result, the cutting wire could not be fully straightened.A photo of the complaint device was provided and showed that the working length was kinked and the device in a bowed position.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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 ; +1(914)571-6918
• MDR Report Key: 25807891
• Report Number: 3005099803-2026-02796
• Device Sequence Number: 13436003
• Product Code: KNS
• UDI-Device Identifier: 08714729444749
• UDI-Public: (01)08714729444749(17)281027(10)37813416
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 0037813416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 10/28/2025
• 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