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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the tip of the cutting wire would no longer relax, causing it to remain bent.It was reported that the device did bow correctly but would not release the bow (unbow).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 b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a050701captures the reportable event of wire was unable to release the bow.Block h11: investigation results.The returned autotome rx 44 was analyzed, and a visual inspection found that the working length was kinked.A functional test was performed, and the device was actuated and was able to bow and unbow inside and outside of the scope.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire failure to release bow (unbow) was not confirmed.The results of the analysis performed on the returned device found that the device was able to bow and unbow inside and outside of the scope as intended.Therefore, the most probable root cause 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 of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the tip of the cutting wire would no longer relax, causing it to remain bent.It was reported that the device did bow correctly but would not release the bow (unbow).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 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: 19646827
• Report Number: 3005099803-2024-03106
• Device Sequence Number: 15387013
• Product Code: KNS
• UDI-Device Identifier: 08714729444756
• UDI-Public: 08714729444756
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 09/05/2024

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: 10/02/2026
• Device Model Number: M00545180
• Device Catalogue Number: 4518
• Device Lot Number: 0032561699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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