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

Model Number	M00545150
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 49 was attempted to be used in a procedure performed on (b)(6) 2025.During the procedure, it was reported that after the device entered the patient, the autotome rx 49 did bow correctly but would not release the bow.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.
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.Block h11: (investigation result) the returned autotome rx 49 was analyzed, and a visual evaluation noted that the working length was twisted.Functional evaluation revealed that device was able to bow and unbow inside and outside of the scope however, the unbowing was not smooth because the working length was twisted.No other problems with the device were noted.The reported event of the device would not release the bow was confirmed.Upon analysis, it was found that the working length was twisted.The problem could have been generated after multiple attempts to rotate handle of the device or during the introduction of the device into the scope.The twisted working length limits the overall performance of the device making the wire difficult to unbow.Based on all gathered information, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 49 was attempted to be used in a procedure performed on (b)(6) 2025.During the procedure, it was reported that after the device entered the patient, the autotome rx 49 did bow correctly but would not release the bow.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.

• 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: 22037962
• Report Number: 3005099803-2025-02225
• Device Sequence Number: 8112626
• Product Code: KNS
• UDI-Device Identifier: 08714729415138
• UDI-Public: (01)08714729415138(17)270628(10)34335939
• 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,Followup
• Report Date (Section B): 07/21/2025

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: M00545150
• Device Catalogue Number: M00545150
• Device Lot Number: 0034335939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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 Sex: Unknown