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

Model Number	M00573060
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The returned jagtome was analyzed, and a visual evaluation noted that the cutting wire was detached from the active cord insert inside the handle disabling the ability to actuate the device.A functional evaluation could not be performed due to the condition of the device.No other issues with the device were noted.According to the product analysis, the cutting wire was detached from the active cord insert inside the handle.Upon further analysis, the active cord was removed, and the aluminum disc was not present.Based on review and analysis of all available information, the most probable cause of this complaint is manufacturing deficiency.An investigation was opened to address this issue.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was in the papilla duodeni vateri during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the cutting wire of the jagtome was unable to bow.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.This event has been deemed reportable based on the investigation results: cutting wire detached.

• 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
• MDR Report Key: 10171471
• Report Number: 3005099803-2020-02348
• Device Sequence Number: 11298522
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: 08714729776673
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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 Expiration Date: 09/13/2022
• Device Model Number: M00573060
• Device Catalogue Number: 7306
• Device Lot Number: 0024432042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1