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

Model Number	M00583110
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
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 device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 device was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was difficulty advancing the guidewire through the device and when current was applied, the tip was torn and the cutting wire broke.Nothing 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.The patient's condition following the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 device was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was difficulty advancing the guidewire through the device and when current was applied, the tip was torn and the cutting wire broke.Nothing 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.The patient's condition following the procedure was reported to be fine.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: device code 1069 captures the reportable event of wire break.Block h10: the returned truetome jag 44 was analyzed, and a visual evaluation noted the tip was damage, the cutting wire was bent and the working length was bent and twisted.A functional evaluation could not be performed due to the condition of the device.No other issues with the device were noted.The reported event was not confirmed.According to the device analysis, the cutting wire was not broken and the working length was not torn.Additionally, the tip of the device was found damaged, the exposed cutting wire bent, and the working length bent and twisted.The factors that may have contributed to the observed damage include, the technique used by the physician, the patient anatomy, or the device interaction with the scope.Based on the review and analysis of all available information, the most probable root cause 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 directions for use (dfu) / 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: 9825179
• Report Number: 3005099803-2020-00864
• Device Sequence Number: 3037102
• Product Code: KNS
• UDI-Device Identifier: 08714729858652
• UDI-Public: 08714729858652
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122203
• 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,Followup
• Report Date (Section B): 04/23/2020

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: 08/27/2021
• Device Model Number: M00583110
• Device Catalogue Number: 47405
• Device Lot Number: 0024344916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1