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

Model Number	M00584160
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date 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 49 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.The device was tested by bowing it prior to the procedure with no problems noted.During the procedure, when the physician bowed and energized the device to cut, "the metal piece popped out of one side of the device." it was reported that no part of the cutting wire detached and fell into the patient.The device was removed and replaced with another device to complete the procedure.There were no patient complications reported as a result of this event.Note: a photo of the device outside the patient was provided by the customer showing the cutting wire broken and bent.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 49 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.The device was tested by bowing it prior to the procedure with no problems noted.During the procedure, when the physician bowed and energized the device to cut, "the metal piece popped out of one side of the device." it was reported that no part of the cutting wire detached and fell into the patient.The device was removed and replaced with another device to complete the procedure.There were no patient complications reported as a result of this event.Note: a photo of the device outside the patient was provided by the customer showing the cutting wire broken and bent.
Additional Manufacturer Narrative
Block b3: approximated based on the date 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 49 was analyzed, and a visual evaluation noted that the cutting wire was broken and kinked.The device was observed under magnification and the cutting wire was broken, kinked, and blackened.These findings were consistent with the findings per media analysis.It was also found that the working length was torn at the proximal pierced hole.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 generated if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during procedure as per precautions of the device states.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity, which can cause a premature cutting wire fatigue, leading to break it.Additionally kinking/bending the cutting wire can lead to break it.It was also found that the working length was torn which could have been caused by energization of the device during the handle actuation.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.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 49
• Common Device Name: 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: 13713146
• Report Number: 3005099803-2022-01203
• Device Sequence Number: 5433831
• Product Code: KNS
• UDI-Device Identifier: 08714729827627
• UDI-Public: 08714729827627
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: M00584160
• Device Catalogue Number: 8416
• Device Lot Number: 0028472064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown