MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME PRO RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584380
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged or dislocated.
Event or Problem Description
It was reported to boston scientific corporation that an autotome pro rx 44 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat gallstones performed on (b)(6) 2025.During the preparation, the package was opened, and it was observed that the cutting wire was loose, making the device impossible to use.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photo of the complaint device outside the patient was provided by the customer and showed the wire/anchor was dislodged from the catheter.

• Brand Name: AUTOTOME PRO 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22785887
• Report Number: 3005099803-2025-03937
• Device Sequence Number: 15908332
• Product Code: KNS
• UDI-Device Identifier: 00191506039226
• UDI-Public: (01)00191506039226(17)271216(10)35500390
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K232162
• 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
• 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: M00584380
• Device Catalogue Number: M00584380
• Device Lot Number: 0035500390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/12/2025
• Date Device Manufactured: 12/16/2024
• 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: 32 YR
• Patient Sex: Female