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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
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BOSTON SCIENTIFIC CORPORATION FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER Back to Search Results
Lot Number 0033594113
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2024
Event Type  malfunction  
Event Description
It was reported that during an ablation procedure to treat atrial fibrillation a farawave pulsed field ablation catheter was selected for use.The non-boston scientific guidewire became entrapped within the pulmonary veins.The guidewire was advanced and freed; however, it became difficult to advance and retract within the catheter afterwards.The catheter and wire were replaced and the procedure was completed.No patient complications were reported.The device is expected to be returned for analysis.
 
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Brand Name
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
Type of Device
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
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key19177675
MDR Text Key341006448
Report Number2124215-2024-24075
Device Sequence Number1
Product Code QZI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/24/2024
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
Device Operator Health Professional
Device Lot Number0033594113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/24/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/08/2024
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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