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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE PULSED FIELD ABLATION CATHETER; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
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BOSTON SCIENTIFIC CORPORATION FARAWAVE PULSED FIELD ABLATION CATHETER; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER Back to Search Results
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2024
Event Type  malfunction  
Event Description
It was reported that resistance was felt while manipulating the catheter over the guidewire.During an ablation procedure to treat atrial fibrillation (af), a farawave catheter was selected for use.While manipulating the catheter over the guidewire (rosen 0.035, 1.5 mm j, 180 cm by merit) in flower shape, resistance was felt.The catheter was removed from the patient anatomy and was inspected.The resistance was able to be replicated.The catheter was replaced, and the procedure was completed successfully without patient complications.The device has been returned for analysis.
 
Event Description
It was reported that resistance was felt while manipulating the catheter over the guidewire.During an ablation procedure to treat atrial fibrillation (af), a farawave catheter was selected for use.While manipulating the catheter over the guidewire (rosen 0.035, 1.5 mm j, 180 cm by merit) in flower shape, resistance was felt.The catheter was removed from the patient anatomy and was inspected.The resistance was able to be replicated.The catheter was replaced, and the procedure was completed successfully without patient complications.The device has been returned for analysis.
 
Manufacturer Narrative
Upon device return and inspection, it was noted that the catheter was returned with a guidewire still inserted.Some potential tissue was visibly stuck between the guidewire and the guidewire lumen at the tip of the spline cage.When attempting to move the guidewire, it was noted that some resistance was felt, but with some force the guidewire was removed successfully.Deployment of the device was functional.The reported event was confirmed.
 
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Brand Name
FARAWAVE PULSED FIELD ABLATION CATHETER
Type of Device
CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key19213001
MDR Text Key341392321
Report Number2124215-2024-25807
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 04/30/2024
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/10/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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