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

Model Number	M00584470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to two jagtome revolution pro rx 39 and an extractor pro retrieval balloon used in the same procedure.It was reported to boston scientific corporation that a jagtome revolution pro rx 39 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the physician unintentionally cannulated the pancreatic duct three times, but was able to successfully cannulate the common bile duct.Contrast was injected and a normal common bile duct was visualized.The sphincterotome was then pulled back to perform sphincterotomy.The physician had the insulated portion of the cut wire traversing the ampulla orifice but continued to apply upward force and cautery.There was bleeding beyond the ampulla throughout the rest of the case.The physician then removed the sphincterotome and an extractor pro retrieval balloon was advanced over the guidewire without difficulty until he entered the proximal cbd at which point he was not able to advance the balloon any further.Eventually, the balloon was removed and while waiting for the next balloon the physician lost access to the cbd.The guidewire was removed and another sphincterotome of the same kind was opened and prepared by the surgical technician.The physician advanced the second sphincterotome and injected contrast.X-ray image showed the contrast spreading outside the common bile duct.The sphincterotome, guidewire and endoscope were removed from the patient and the procedure was aborted.It was reported that the patient's bleeding and perforation healed on its own without intervention and the patient is in good condition.
Additional Manufacturer Narrative
Patient code e2114 captures the reportable event of perforation.

• Brand Name: JAGTOME REVOLUTION PRO RX 39 SPHINCTEROTOME
• 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: 19334609
• Report Number: 3005099803-2024-02134
• Device Sequence Number: 3009167
• Product Code: KNS
• UDI-Device Identifier: 00191506039318
• UDI-Public: 00191506039318
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2025
• Device Model Number: M00584470
• Device Catalogue Number: 8447
• Device Lot Number: 0033171771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown