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

Model Number M00584260

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a jagtome revolution rx was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, while the jagtome revolution rx was energized to perform sphincterotomy, the cutting wire broke.It was reported that the cutting wire detached but it stayed attached to the device.The physician removed the device and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the cutting wire was broken and kinked.

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis of could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: JAGTOME REVOLUTION RX
• Type of Device: 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: 15067229
• MDR Text Key: 304337911
• Report Number: 3005099803-2022-03925
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729953258
• UDI-Public: 08714729953258
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2022

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
• Device Operator: Health Professional
• Device Model Number: M00584260
• Device Catalogue Number: 8426
• Device Lot Number: 0029165333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1