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

Model Number	M00545180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the cutting wire of the autotome rx broke off.The cutting wire was still attached but the other end broke off.It was reported that there was a part of the cutting wire detached and fell into the patient, which successfully retrieved.It was unknown what device was used to retrieve the detached piece.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
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 h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the cutting wire detached from the anchor, but the anchor was still inside the catheter.The device was observed under magnification and found the working length torn from the end of the rx channel to the tip.The distal tip components were inspected under x-ray, and found evidence of lack of soldering between the cutting wire and the anchor.No other problems with the device were noted.The reported event of cutting wire break was not confirmed; however, upon analysis, it was found that the cutting wire was detached from the anchor.It was found that the working length was torn from the end of the rx channel to the tip, which is typically caused when the user pulls or removes the guidewire through the c-channel.It is also possible that the technique used during loading/removing the guidewire into the device could cause the catheter to tear.X-ray images revealed a lack of solder between the cutting wire and the anchor.Based on all available information, the most probable root cause of the event is manufacturing deficiency, since the problems were traced to manufacturing process.An investigation to address this problem has been initiated.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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the cutting wire of the autotome rx broke off.The cutting wire was still attached but the other end broke off.It was reported that there was a part of the cutting wire detached and fell into the patient, which successfully retrieved.It was unknown what device was used to retrieve the detached piece.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: 16422442
• Report Number: 3005099803-2023-00881
• Device Sequence Number: 6601927
• Product Code: KNS
• UDI-Device Identifier: 08714729444756
• UDI-Public: 08714729444756
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2025
• Device Model Number: M00545180
• Device Catalogue Number: 4518
• Device Lot Number: 0029986890
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown