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

Model Number	M00584240
Medical Device Problem Codes	Peeled/Delaminated (1454); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.
Event or Problem Description
Note: this report pertains to a jagtome revolution rx, advanix pancreatic stent and naviflex pusher used in the same patient and procedure.It was reported to boston scientific corporation that a jagtome revolution rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the physician wants to place a prophylactic pancreatic stent to reduce (ercp) pancreatitis.The pancreatic stent was pushed over the wire and could not advance all the way into the duct.They then tried anchoring the wire with the scope elevator and the wire's jacket started ripping off the wire.They tried flushing the scope channel with water and saline to wet the wire, but it did not work.Eventually they had to pull the scope out because the stent was going to be lodged in the scope channel and ended up losing wire access once they pulled the scope.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.Block h11: the returned jagtome revolution rx was analyzed, and a visual and microscopic evaluation noted that the working length was twisted at distal section and had contrast residues.Media analysis indicates no problem was observed.No other problems with the device were noted.The product analysis of the returned device revealed that the working length was twisted at distal section and had contrast residues.These conditions could be caused after multiple attempts to rotate the handle of the device or during the introduction of the device into the scope.Based on all gathered information, the most probable root cause could not be established.
Event or Problem Description
Note: this report pertains to a jagtome revolution rx, advanix pancreatic stent and naviflex pusher used in the same patient and procedure.It was reported to boston scientific corporation that a jagtome revolution rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the physician wants to place a prophylactic pancreatic stent to reduce (ercp) pancreatitis.The pancreatic stent was pushed over the wire and could not advance all the way into the duct.They then tried anchoring the wire with the scope elevator and the wire's jacket started ripping off the wire.They tried flushing the scope channel with water and saline to wet the wire, but it did not work.Eventually they had to pull the scope out because the stent was going to be lodged in the scope channel and ended up losing wire access once they pulled the scope.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

• Brand Name: JAGTOME REVOLUTION RX
• 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: 19943005
• Report Number: 3005099803-2024-03780
• Device Sequence Number: 4929335
• Product Code: KNS
• UDI-Device Identifier: 08714729953234
• UDI-Public: 08714729953234
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/20/2024

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: M00584240
• Device Catalogue Number: 8424
• Device Lot Number: 0033748217
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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: Female