MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number	0035631169
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that while opening a farawave catheter the irrigation port shows cloudy and suspected contamination.The catheter was opened but not used therefore, no patient involvement.Replacement was requested.It is unknown if the device is going to be returned for laboratory analysis.
Additional Manufacturer Narrative
Additional information to e: initial reporter.It was noted that the facility did retain two catheters, the remaining catheters will be returned for analysis.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 or Problem Description
It was reported that while opening a farawave catheter the irrigation port shows cloudy and suspected contamination.The catheter was opened but not used therefore, no patient involvement.Replacement was requested.It is unknown if the device is going to be returned for laboratory analysis.
Additional Manufacturer Narrative
Five pictures of issue was provided, it is possible to observe some white section through the flush tubing which seems to be part of the assembly between the flush tubing and the flush luer.The product was not returned for analysis to identify any defect with the device; therefore, the reported issue cannot be established due to lack of evidence.
Event or Problem Description
It was reported that while opening a farawave catheter the irrigation port shows cloudy and suspected contamination.The catheter was opened but not used therefore, no patient involvement.Replacement was requested.It is unknown if the device is going to be returned for laboratory analysis.

• Brand Name: FARAWAVE
• Common Device Name: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22438531
• Report Number: 2124215-2025-45351
• Device Sequence Number: 14610395
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)270115(10)35631169
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 0035631169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 08/07/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/16/2025; 08/25/2025
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown