MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00545200
Medical Device Problem Codes	Failure to Fold (1255); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material in the device.
Event or Problem Description
Note: this report pertains to four autotome rx 39 used in the same procedure.It was reported to boston scientific corporation that an autotome rx 39 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the preparation, the autotome was not bowing at the distal end of the device and was instead bowing near the handle of the tome.The procedure was completed with another autotome rx 39.There were no reported patient complications as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and shows a rust like material in the device.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material in the device.Block h11: (investigation results) the returned autotome rx 39 was analyzed, and a visual evaluation noted that the device had evidence of foreign material in the cutting wire lumen and the working length was torn near to the guidewire introducer.Functional evaluation noted that the wire was unable to bow.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of foreign material present in the device was confirmed.The product analysis revealed that the device had evidence of foreign material at several sections in the cutting wire lumen and the unit presented corrosion process through the surface of the wire, except for the handle and the distal section and because of this condition the wire was unable to bow.The working length torn could be caused due to many unsuccessful attempts to actuate the handle, since the wire was unable to bow.Based on all gathered information, the most probable root cause of this complaint is quality control deficiency.An investigation to address this problem is in progress.
Event or Problem Description
Note: this report pertains to four autotome rx 39 used in the same procedure.It was reported to boston scientific corporation that an autotome rx 39 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the preparation, the autotome was not bowing at the distal end of the device and was instead bowing near the handle of the tome.The procedure was completed with another autotome rx 39.There were no reported patient complications as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and shows a rust like material in the device.

• Brand Name: AUTOTOME RX 39
• 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: 22162609
• Report Number: 3005099803-2025-02585
• Device Sequence Number: 8842404
• Product Code: KNS
• UDI-Device Identifier: 08714729444770
• UDI-Public: (01)08714729444770(17)270122(10)33273015
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: M00545200
• Device Catalogue Number: M00545200
• Device Lot Number: 0033273015
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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