MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00545160
Medical Device Problem Codes	Failure to Conduct (1114); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 49 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2025.During the procedure, it was reported that the device contact was poor and the power supply was not continuous.The procedure was completed with another of the same device.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.This event has been deemed a reportable event based on the investigation finding of device cutting wire kinked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable investigation result of cutting wire kinked.Block h11: (investigation result) the returned autotome rx 49 was analyzed, and a visual evaluation noted that the cutting wire was kinked, and the working length was twisted.Continuity and electrical evaluation shows the device was within specification.No other problems with the device were noted.After analysis of the returned device, it was determined that the cutting wire was kinked.These conditions could have been generated by operational factors, such as manipulating the device through difficult anatomy, the technique used for the device manipulation or by the interaction between the device and the scope (hitting against a hard surface).The twisted working length could be caused after multiple attempts to rotate handle of the device or during the introduction of the device into the scope.Additionally, an electrical test was performed and the resistance across the 2-in-1 connector and the cutting wire must be less or minus 20 ohms and the result shows 13.9 ohms which was within specification and showed continuity.Based on all gathered information, the most probable root cause is adverse event related to procedure.

• Brand Name: AUTOTOME RX 49
• 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: 22786322
• Report Number: 3005099803-2025-03836
• Device Sequence Number: 21343580
• Product Code: KNS
• UDI-Device Identifier: 08714729415152
• UDI-Public: (01)08714729415152(17)270319(10)33660125
• 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): 08/12/2025

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: M00545160
• Device Catalogue Number: M00545160
• Device Lot Number: 0033660125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 61 KG