MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LEVEEN STANDARD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	36721
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced bradycardia and a brief period of asystole.Preliminary ultrasonography showed a 1.3x1.6 cm hypoechouc nodule in hepatic segment vi.The patient was prepared in supine position under aseptic draping and combined general-local anesthesia for a radiofrequency ablation (rfa) procedure.A 4.0 cm leveen rfa needle was navigated into the nodule ultrasonographic guidance.Ablation was performed and during first position of ablation (about 10 mins at about 170 watts) with 4.0 diameter of expansion, the patient developed bradycardia (heart rate from 80 bpm to 30 bpm) and then asystole (duration about 2-3 seconds) and spontaneous recovery.The events of bradycardia occurred about 5-6 cycles.0.3 mg of atropine was given by anesthesiologist.Then the session was stopped.Total ablative time was about 13 minutes.Re-ablation was done at 130 watts and the patient developed bradycardia again.The session was then terminated.Mild hyperechoic change was seen and the tract was ablated.The patient's condition was stable.
Event or Problem Description
It was reported the patient experienced bradycardia and a brief period of asystole.Preliminary ultrasonography showed a 1.3x1.6 cm hypoechouc nodule in hepatic segment vi.The patient was prepared in supine position under aseptic draping and combined gereral-local anesthesia for a radiofrequency ablation (rfa) procedure.A 4.0 cm leveen rfa needle was navigated into the nodule ultrasonographic guidance.Ablation was performed and during first position of ablation(about 10 mins at about 170 watts) with 4.0 diameter of expansion, the patient developed bradycardia (heart rate from 80 bpm to 30 bpm) and then asystole (duration about 2-3 seconds) and spontaneous recovery.The events of bradycardia occurred about 5-6 cycles.0.3 mg of atropine was given by anesthesiologist.Then the session was stopped.Total ablative time was about 13 minutes.Re-ablation was done at 130 watts and the patient developed bradycardia again.The session was then terminated.Mild hyperechoic change was seen and the tract was ablated.The patient's condition was stable.It was further reported that the physician believes the cause of the bradycardia/asystole was parasympathetic stimulation.The patients status is currently (b)(6) - restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.

• Brand Name: LEVEEN STANDARD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7850430
• Report Number: 2134265-2018-60792
• Device Sequence Number: 19291630
• Product Code: GEI
• UDI-Device Identifier: 08714729295594
• UDI-Public: 08714729295594
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K140500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: 36721
• Device Catalogue Number: 36721
• Device Lot Number: 0021409135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/30/2018
• 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: Other
• Patient Age: 65 YR