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

Model Number	M00545150
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 49 was used in the papilla during a normal duodenal papillary incision procedure performed on (b)(6) 2023.During the procedure, the cutting wire of sphincterotome was damaged.It was reported that the wire anchor was dislodged, and no part of the cutting wire detached and fell into the patient.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
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged.The returned autotome rx 49 was analyzed, and a visual evaluation noted that the cutting wire was broken at 7mm from the proximal pierced hole and also it was kinked, which are consistent with the findings when the device was observed under magnification.Additionally, the broken cutting wire was blackened, and the anchor was still inside the catheter in its original position.No other problems with the device were noted.The reported event of wire anchor dislodged was not confirmed as it was possible to observe that the anchor was still inside the catheter.Upon analysis, it was found that the cutting wire was broken, kinked and blackened.The cutting wire being blackened indicates that the device was energized.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.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.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16593157
• Report Number: 3005099803-2023-01531
• Device Sequence Number: 5088429
• Product Code: KNS
• UDI-Device Identifier: 08714729415138
• UDI-Public: 08714729415138
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/22/2023

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: 4515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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