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

Model Number	M00545170
Medical Device Problem Codes	Break (1069); Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2026.During the procedure, the device functioned normally on its first use.However, there was no response when it was activated a second time, and repeated attempts produced the same result.The autotome was then withdrawn, and examination revealed that its tip had fractured.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.The reported event may suggest that the cutting wire broke.There were no patient complications reported as a result of this event and 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 ; EI 01752 ; 9145716918
• MDR Report Key: 25566219
• Report Number: 3005099803-2026-02531
• Device Sequence Number: 21331084
• Product Code: KNS
• UDI-Device Identifier: 08714729444749
• 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): 09/01/2026

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: 0037872139
• 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: 05/25/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 165 LB