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

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/04/2024

Event Type  Injury  

Manufacturer Narrative

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 medwatch will be filed.

Event Description

Faradise clinical study: clinical study id: (b)(4), clinical patient id: (b)(6).During an emergent follow up after a procedure using a farawave pulsed field ablation catheter the patient experienced oral bleeding that prolonged hospitalization.It is unknown how the complication was resolved.It is unknown if the catheter will be returned for analysis.

Event Description

Faradise clinical study: clinical study id: pf114, clinical patient id: (b)(6).During an emergent follow up after a procedure using a farawave pulsed field ablation catheter the patient experienced oral bleeding that prolonged hospitalization.It is unknown how the complication was resolved.It is unknown if the catheter will be returned for analysis.It was further reported that the oral bleeding was believed to be caused by the patient being intubated as part of the sedation protocol for the index procedure or the trans-esophageal echo exam performed to guide the transeptal puncture.The bleeding cleared after one day and hospitalization was prolonged for that extra day.The patient completely recovered from the bleeding.The device is not expected to be returned for analysis due to disposal.

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.

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

Faradise clinical study: clinical study id: (b)(6) , clinical patient id: (b)(6).During an emergent follow up after a procedure using a farawave pulsed field ablation catheter the patient experienced oral bleeding that prolonged hospitalization.It is unknown how the complication was resolved.It is unknown if the catheter will be returned for analysis.It was further reported that the oral bleeding was believed to be caused by the patient being intubated as part of the sedation protocol for the index procedure or the trans-esophageal echo exam performed to guide the transeptal puncture.The bleeding cleared after one day and hospitalization was prolonged for that extra day.The patient completely recovered from the bleeding.The device is not expected to be returned for analysis due to disposal.It was further reported that nasal and oral fibroscopy was performed for diagnostic purposes.Bleeding was noted from the left nasal turbinate.The bleeding occurred prior to discharge from the hospital after the procedure had been completed.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): FARAPULSE, INC.; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer (Section G): AGILE MV INC; 3700 st patrick st suite 102; montreal, qc H4E 1 A2; CA H4E 1A2
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18748865
• MDR Text Key: 335931751
• Report Number: 2124215-2024-10222
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 75 KG