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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
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BOSTON SCIENTIFIC CORPORATION FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM Back to Search Results
Lot Number 0033378810
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Event Description
It was reported that the device could not be returned to a nominal position after deployment; unable to undeploy.Prior to an ablation procedure to treat atrial fibrillation (af), a farawave catheter was selected for use.Before insertion, the device deployment was tested from basket to flower, and it was observed that the catheter could not undeploy to a nominal position.The catheter was replaced, and the procedure was completed successfully without patient complications.The device is expected to be returned for analysis.
 
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Brand Name
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
Type of Device
FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
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 Key19018802
MDR Text Key339101773
Report Number2124215-2024-19504
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
Reporter Occupation Physician
Type of Report Initial
Report Date 04/02/2024
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 Number0033378810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received04/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2024
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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