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

Model Number	M00545150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 49 was used in a procedure performed on (b)(6) 2021.When the autotome rx 49 device was used, the cutting broke.The procedure was completed with another of the same device.There were no reported patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Additional information: block b5, block h6 (patient codes), block h6 (impact codes).Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned autotome rx 49 was analyzed, and a visual evaluation noted that the cutting wire was broken, blackened and kinked.The cutting wire was observed under magnification and the cut of the cutting wire was not smooth, and the cutting wire was blackened.It was also found that the device was cut at the proximal section and the cutting wire was pulled out of the device which indicates that a mechanical tool was used to cut the device.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, blackened, and kinked.Additionally, the device was cut at the proximal section.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during procedure as per precautions of the device states.Also, kinking of the cutting wire can lead to wire break.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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 rx 49 was used in the duodenal papilla during an endoscopic sphincterotomy (est) procedure performed on april 2, 2021.During the procedure, after applying current to the autotome rx 49, when the physician tried to bow the device again, it was noticed that the cutting wire broke.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.

• 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
• MDR Report Key: 11700518
• Report Number: 3005099803-2021-01791
• Device Sequence Number: 3436317
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 11/02/2023
• Device Model Number: M00545150
• Device Catalogue Number: 4515
• Device Lot Number: 0026290872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1