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

Model Number	M00583140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date is unknown.During the procedure, an initial cut of the papilla was made.The activation of the cutting wire was stopped as the device was being repositioned in preparation for the second cut; however, it was noticed that the cutting wire broke at this time.No part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date is unknown.During the procedure, an initial cut of the papilla was made.The activation of the cutting wire was stopped as the device was being repositioned in preparation for the second cut; however, it was noticed that the cutting wire broke at this time.No part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date (b)(6)2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned truetome jag 44 was analyzed, and a visual evaluation noted that the cutting wire was broken.The working length was also cut.The returned working length and cutting wire were incomplete as the separated sections were not returned.The returned parts of the device were observed under magnification and the the end of the cut section in the working length showed signs of a mechanical cut using a sharp tool.Additionally, the cutting wire was blackened.The dimensional and functional evaluation were not performed due to the condition of the device.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken, and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused most likely due to a peak of voltage rating or if the device was not in contact with the tissue when it was energized.Additionally, the working length was found mechanically cut, which indicates that the device was not correctly manipulated.These conditions could have been generated during manipulation of the device, due to the interaction with the endoscope and/or with other devices.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: TRUETOME JAG 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: 11816085
• Report Number: 3005099803-2021-02046
• Device Sequence Number: 3767455
• Product Code: KNS
• UDI-Device Identifier: 08714729858683
• UDI-Public: 08714729858683
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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: 10/29/2022
• Device Model Number: M00583140
• Device Catalogue Number: 8314
• Device Lot Number: 0026272940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1