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

Model Number	M00573100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer received the device.(b)(4).Visual examination of the returned device revealed that the cutting wire was broken and blackened.Functionally, water was injected into the jagtome and there was no leakage in the working length and contrast port noted.It was found during investigation that the cutting wire was broken.It is most likely that a peak of voltage could have caused the failures noted.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
Event or Problem Description
Boston scientific received a jagtome rx 39 device with no associated information.Evaluation of the device revealed a broken cutting wire.Follow up with the sender revealed that this jagtome rx 39 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure.They were trying to increase the size of the sphincterotomy, and the patient already had a metal stent in place.Possibly, the cut wire touched the metal stent and broke at that point.Reportedly, no part of the device detached inside the patient.The procedure was completed with this device with no further action needed.There were no patient complications reported as a result of this event.

• 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: 8773772
• Report Number: 3005099803-2019-03414
• Device Sequence Number: 19254839
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: 08714729776536
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

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: 02/13/2022
• Device Model Number: M00573100
• Device Catalogue Number: 7310
• Device Lot Number: 0023351209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1