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

Model Number	M00545180
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the papilla vateri during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, upon cannulating the papilla, it was noticed that the device remained in a bowed position and would not release the bow.They tried to bow and unbow the device, but nothing happened.The handle had no tension.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and showed the device in a bowed position.
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire unable to release the bow.
Additional Manufacturer Narrative
Block h6: imdrf device code a050701captures the reportable event of wire unable to release the bow.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the working length was kinked in several sections, including the cutting wire, which are consistent with the findings when the device was observed under magnification.Per media inspection on the provided photo, it did not show any visual problems of the device.Per functional inspection, the device was inserted through the scope, and it was able to bow and unbow as intended both inside and outside of the scope.Per the dimensional inspection, the distance between the distal pierce hole to the proximal pierce hole was within specification.No other problems with the device were noted.The reported event of wire unable to release bow (unbow) was not confirmed.Upon analysis, it was found that the working length was kinked, which could have been caused by operational factors, such as manipulating the device through difficult anatomy or the used technique for the device manipulation.Additionally, it was observed that the cutting wire was kinked, which could have occurred due to the device interaction with the scope like the insertion-removal, hitting it against a hard surface (scope), which can lead to kink/bend the cutting wire.When the device was functionally tested, the device bowed and returned from the bow as intended.The distance between the distal pierce hole to the proximal pierce hole was within specification, and the returned did not show evidence of the alleged problem; therefore, the most probable root cause of this complaint is no problem detected.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 44 was used in the papilla vateri during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, upon cannulating the papilla, it was noticed that the device remained in a bowed position and would not release the bow.They tried to bow and unbow the device, but nothing happened.The handle had no tension.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and showed the device in a bowed position.

• Brand Name: AUTOTOME 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18067290
• Report Number: 3005099803-2023-05912
• Device Sequence Number: 18038613
• Product Code: KNS
• UDI-Device Identifier: 08714729444756
• UDI-Public: 08714729444756
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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 Expiration Date: 04/19/2026
• Device Model Number: M00545180
• Device Catalogue Number: 4518
• Device Lot Number: 0031466636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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 Sex: Unknown