MAUDE Adverse Event Report: FARAPULSE, INC. FARASTAR PULSED FIELD ABLATION GENERATOR; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR

Lot Number 0102509127

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

Patient Problem Electric Shock (2554)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during an irreversible electroporation ablation procedure using a farastar generator a nurse felt a tingling/shock during energization.No specific information was provided about the incident, and it was stated to have occurred "months ago" no interventions were reported, and no further complications were stated to have occurred.A field service engineer has been dispatched to examine the console.

Manufacturer Narrative

The device was not returned to boston scientific for analysis; however, a field service engineer (fse) did visit the generator at the site.The fse performed functional testing and electrical safety testing and the console passed both tests successfully.Based on all available information boston scientific has not been able to confirm the event and cause not established was selected as the conclusion code.

Event Description

It was reported that during an irreversible electroporation ablation procedure using a farastar generator a nurse felt a tingling/shock during energization.No specific information was provided about the incident, and it was stated to have occurred "months ago" no interventions were reported, and no further complications were stated to have occurred.A field service engineer has been dispatched to examine the console.

• Brand Name: FARASTAR PULSED FIELD ABLATION GENERATOR
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR
• Manufacturer (Section D): FARAPULSE, INC.; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18767412
• MDR Text Key: 336111333
• Report Number: 2124215-2024-10777
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/23/2024

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
• Device Operator: Health Professional
• Device Lot Number: 0102509127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other