MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the lot expiration and device manufacture dates are unknown.(b)(64.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the distal bile duct during a bile duct stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that upon bowing the cutting wire to perform the endoscopic sphincterotomy, the proximal side of the wire got separated.There was no part of the device detached inside the patient.There were no injury nor patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the distal bile duct during a bile duct stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that upon bowing the cutting wire to perform the endoscopic sphincterotomy, the proximal side of the wire got separated.There was no part of the device detached inside the patient.There were no injury nor patient complications reported as a result of this event.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the lot expiration and device manufacture dates are unknown.Problem code 1069 captures the reportable event of wire broke.Visual examination of the returned device revealed that the cutting wire was broken and blackened.There was no other issue noted.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 manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

• Brand Name: JAGTOME RX 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8309048
• Report Number: 3005099803-2019-00251
• Device Sequence Number: 19315073
• Product Code: KNS
• UDI-Device Identifier: 08714729776666
• UDI-Public: 08714729776666
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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 Model Number: M00573050
• Device Catalogue Number: 7305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1