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	Electric Shock (2554)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that jagtome rx 39 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician went to perform sphincterotomy, it was noticed that the cutting wire broke off.The detached part was retrieved from the patient using a rat tooth forceps.Reportedly, the patient had a jolt reflex and had felt some electric current shock when the wire broke off.The procedure was completed with a different device, using the same generator and active cord.The patient's condition at the end of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that jagtome rx 39 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician went to perform sphincterotomy, it was noticed that the cutting wire broke off.The detached part was retrieved from the patient using a rat tooth forceps.Reportedly, the patient had a jolt reflex and had felt some electric current shock when the wire broke off.The procedure was completed with a different device, using the same generator and active cord.The patient's condition at the end of the procedure was reported to be fine.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device revealed that the cutting wire was broken and blackened.The complaint was consistent with the reported event of cutting wire broke.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.The device history record review was performed and no anomalies were observed.The review confirmed that the device met all manufacturing specifications.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

• 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: 8373785
• Report Number: 3005099803-2019-00919
• Device Sequence Number: 11197495
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: 08714729776536
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: M00573100
• Device Catalogue Number: 7310
• Device Lot Number: 22181447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention