MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure 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
Note: this report pertains to the first of two truetome 49 devices used during the same procedure.It was reported to boston scientific corporation that a truetome 49 was used in the cannulation of ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the cutting wire broke.A second truetome was used; however, the cutting wire was also broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a different tome.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h10: the returned truetome 49 was analyzed, and a visual evaluationnoted that the exposed cutting wire was detached and blackened with a non smooth surface.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 confirmed.Upon analysis of the returned device, the exposed cutting wire was found detached and blackened with a non smooth surface.The failure found could had been generated if the device was not completely in contact with the tissue during energization or if there was contact between the scope and the cutting wire while electrical current was applied.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 the device met all manufacturing specifications.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
Note: this report pertains to the first of two truetome 49 devices used during the same procedure.It was reported to boston scientific corporation that a truetome 49 was used in the cannulation of ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the cutting wire broke.A second truetome was used; however, the cutting wire was also broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a different tome.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: TRUETOME 49
• 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: 10385818
• Report Number: 3005099803-2020-03229
• Device Sequence Number: 19301548
• Product Code: KNS
• UDI-Device Identifier: 08714729827627
• UDI-Public: 08714729827627
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 05/13/2022
• Device Model Number: M00584160
• Device Catalogue Number: 8416
• Device Lot Number: 0025511353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 170