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

Model Number 36721

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 08/14/2018

Event Type  Injury  

Event 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 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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7850430
• MDR Text Key: 119350348
• Report Number: 2134265-2018-60792
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08714729295594
• UDI-Public: 08714729295594
• Combination Product (y/n): N
• PMA/PMN Number: K140500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR