MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573100
Medical Device Problem Codes	Break (1069); Failure to Conduct (1114)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 jagtome rx 39 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after advancing the tome through the scope to the ampulla, sphincterotomy was initiated with a small cut.When the physician attempted to continue the sphincterotomy, the cutting wire was unable to conduct.It was then noticed that the cutting wire broke at the poximal end; however, the distal end was still attached.Reportedly, no part of the device was detached inside the patient.The procedure was completed with a jagtome rx 44, 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 fine.

• Brand Name: JAGTOME RX 39
• 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: 9316739
• Report Number: 3005099803-2019-05576
• Device Sequence Number: 468527
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: 08714729776536
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• 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): 11/13/2019

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: 06/16/2022
• Device Model Number: M00573100
• Device Catalogue Number: 7310
• Device Lot Number: 0023966037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1