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

Model Number	M00573060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e0506 captures the reportable event of bleeding.Imdrf impact code f2301 captures the reportable event of placing a metal stent to stop the bleeding.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 20224.During the procedure, the physician entered the papilla with the device, the nurse bowed the device and the physician added energy from the generator.It was reported that bleeding was immediate after sphincterotomy, resulting in heavy bleeding and hematoma.The procedure was able to be completed using the original jagtome rx 44 device.The patient had heavy bleeding and hematoma.A metal stent was placed to stop the bleeding and the patient was reported to be fully recovered.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the physician entered the papilla with the device, the nurse bowed the device and the physician added energy from the generator.It was reported that bleeding was immediate after sphincterotomy, resulting in heavy bleeding and hematoma.The procedure was able to be completed using the original jagtome rx 44 device.The patient had heavy bleeding and hematoma.A metal stent was placed to stop the bleeding and the patient was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf patient code e0506 captures the reportable event of bleeding.Imdrf impact code f2301 captures the reportable event of placing a metal stent to stop the bleeding.Block h11: the returned jagtome rx 44 was analyzed, and a visual evaluation and microscopic inspection found no visible damages to the device.An electrical test was performed and the resistance across the 2-in-1 connector and the cutting wire was within specification, and the device showed continuity.The customer provided a picture of an erbe device showing the program setting of the procedure, but no device was seen in the picture.No other problems with the device were noted.Upon analysis, the returned device did not show evidence of physical damages and electrical testing was within specification.The reported adverse events of "hematoma" and "hemorrhage, major" were noted as risks in the instructions for use (ifu)."potential complications include, but are not limited to: pancreatitis; perforation; hemorrhage; hematoma; cholangitis; stone impaction; septicemia/infection; allergic reaction to contrast medium.Possible electrosurgical adverse effects include: fulguration; burns; stimulation; cardiac arrhythmias." based on all gathered information, the most probable root cause of this complaint is known inherent risk of device.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: JAGTOME 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: 19912242
• Report Number: 3005099803-2024-03641
• Device Sequence Number: 8618853
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: 08714729776673
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/07/2024

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 Model Number: M00573060
• Device Catalogue Number: 7306
• Device Lot Number: 0033201347
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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