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	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 49 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during procedure, it was noticed that the cutting wire broke when they bowed the tome.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a second trueome 49, using the same generator and active cord.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 good.

• 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: 8735723
• Report Number: 3005099803-2019-03283
• Device Sequence Number: 19345180
• 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
• Report Date (Section B): 06/25/2019

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: 02/10/2021
• Device Model Number: M00584160
• Device Catalogue Number: 8416
• Device Lot Number: 0023328736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1