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

Model Number	M00584380
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an autotome pro rx 44 cannulating sphincterotome was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During sphincterotomy procedure, it was noticed that the papilla was very low hanging, and then the cutting wire of the device broke.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block b5, h6 (additional information) block b5 (describe event of problem) and h6 (device code) have been updated based on the additional information received on march 13, 2024.Block h10: the returned autotome pro rx 44 cannulating sphincterotome was analyzed, and a visual evaluation noted that the cutting wire was broken and kinked from the proximal pierced hole, which are consistent with the findings when the device was observed under magnification.Additionally, the cutting wire were blackened.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken, kinked and blackened.Based on the condition of the device, the problem found could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity and cause a premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can lead to the broken section hitting the working channel of the scope.This can kink the cutting wire.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an autotome pro rx 44 cannulating sphincterotome was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During sphincterotomy procedure, it was noticed that the papilla was very low hanging, and then the cutting wire of the device broke.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the exposed cutting wire was not fully exited the endoscope when the device was energized; however, according to the instructions for use (ifu), verify that the cutting wire has exited the endoscope by visualizing it on the endoscope monitor.Failure to do so may result in contact between the cutting wire and the endoscope while electrical current is applied.This may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the endoscope.

• Brand Name: AUTOTOME PRO RX 44 CANNULATING SPHINCTEROTOME
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18861845
• Report Number: 3005099803-2024-00752
• Device Sequence Number: 8360488
• Product Code: KNS
• UDI-Device Identifier: 00191506039226
• UDI-Public: 00191506039226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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 Expiration Date: 11/22/2024
• Device Model Number: M00584380
• Device Catalogue Number: 8438
• Device Lot Number: 0032915188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: Black Or African American