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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, a jagwire guidewire was preloaded with the truetome 49 through the duodenoscope.When the physician used the truetome 49 with electrocautery, the cutting wire broke.No part of the cutting wire detached and fell into the patient.Reportedly, the device was not energized prior to bowing and when not in contact with the tissue.Also, the exposed cutting wire had fully exited the endoscope when the device was energized.It was confirmed that there was no device deficiency with the jagwire guidewire during use and it was the same original jagwire guidewire used to complete the procedure together with a second truetome 49.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 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 at 24 mm from the distal end.Additionally, the working length was bent at the distal section.The device was observed under magnification and the cutting wire was blackened, the cut of the cutting wire was not smooth.A functional evaluation was not performed due to the condition of the cutting wire.A media inspection of the photos provided by the customer show the generator used and the device inside the patient with the cutting wire detached.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 be caused if the device was not in direct and constant contact with the tissue when applying electrocautery current.Also, energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity.Additionally, the working length was bent which could be caused if the device was hit against a hard surface when advancing into the endoscope.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.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 49 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, a jagwire guidewire was preloaded with the truetome 49 through the duodenoscope.When the physician used the truetome 49 with electrocautery, the cutting wire broke.No part of the cutting wire detached and fell into the patient.Reportedly, the device was not energized prior to bowing and when not in contact with the tissue.Also, the exposed cutting wire had fully exited the endoscope when the device was energized.It was confirmed that there was no device deficiency with the jagwire guidewire during use and it was the same original jagwire guidewire used to complete the procedure together with a second truetome 49.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: 11226388
• Report Number: 3005099803-2021-00201
• Device Sequence Number: 11671907
• Product Code: KNS
• UDI-Device Identifier: 08714729827627
• UDI-Public: 08714729827627
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 02/24/2021

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: 07/29/2022
• Device Model Number: M00584160
• Device Catalogue Number: 8416
• Device Lot Number: 0025786205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 57