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

Model Number	M00545200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.
Event or Problem Description
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 an unknown date.During the procedure, the cutting wire snapped during an attempt to perform a sphincterotomy.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results- the returned autotome rx 39 was analyzed, and a visual inspection found no visible damages to the device; the cutting wire was not broken.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was not confirmed.The results of the analysis performed on the returned device found no visual damages to the device.The investigation findings and all information available concludes the most probable root cause is no problem detected.
Event or Problem Description
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 an unknown date.During the procedure, the cutting wire snapped during an attempt to perform a sphincterotomy.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another device.There were no patient complications reported as a result of this event.

• 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: 22398591
• Report Number: 3005099803-2025-03036
• Device Sequence Number: 4799305
• Product Code: KNS
• UDI-Device Identifier: 08714729444770
• UDI-Public: (01)08714729444770(17)280316(10)36085314
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/28/2025

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: 0036085314
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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