MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00545190
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, to boston scientific corporation.That an autotome rx 39 was attempted to be used in the common bile duct (cbd), during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guidewire could not advance inside the device.It was reported, that a foreign object or substance was inside the guidewire port of the device.The procedure was completed with another autotome rx 39 device.There were no patent complications reported, as a result of this event.Note: a photo of the device, outside the patient was provided by the customer.And a brown colored foreign substance can be seen inside the working length of the device.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures, the reportable event of foreign material in the device.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material in the device.Block h11: the returned autotome rx 39 was analyzed, and a visual and microscopic evaluation found no damages to the device and the device had no evidence of foreign material.Functional testing using a 0.035in guidewire was performed and found the guidewire was able to advance through the entire length of the device.Media inspection of the photo provided by the customer found it was possible to observe the handle and the distal section of the device, but it was not possible to observe the guidewire introducer to determine if there was presence of foreign material.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of foreign material present in the device was unable to be confirmed.The product analysis revealed that the device did not have any visible damage or evidence of any foreign material.The guidewire was able to advance without problem during functional testing.A photo of the handle and the distal section of the device was provided by the customer, but it was not possible to observe the guidewire introducer and determine if there was presence of foreign material.Based on all gathered information, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 39 was attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guidewire could not advance inside the device.It was reported that a foreign object or substance was inside the guidewire port of the device.The procedure was completed with another autotome rx 39 device.There were no patent complications reported as a result of this event.Note: a photo of the device outside the patient was provided by the customer and a brown colored foreign substance can be seen inside the working length of the device.

• Brand Name: AUTOTOME RX 39
• 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: 20049867
• Report Number: 3005099803-2024-03998
• Device Sequence Number: 7896139
• Product Code: KNS
• UDI-Device Identifier: 08714729444763
• UDI-Public: 08714729444763
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 10/30/2024

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 Model Number: M00545190
• Device Catalogue Number: 4519
• Device Lot Number: 0032807661
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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