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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 87047
Device Problems Insufficient Flow or Under Infusion (2182); Material Deformation (2976); Material Integrity Problem (2978); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2023
Event Type  malfunction  
Event Description
The intellanav mifi open-irrigated ablation catheter was selected for use during an ablation procedure to treat atrial fibrillation.It was reported that during procedure they noticed there was a problem with the catheter's irrigation port.It was noted that they rotated the catheter handle a bit too much which broke the irrigation port.The side port was kinking which caused the catheter's temperature to become too high as the pump was unable to irrigate it.A high temperature error had occurred, rising above 35 during the ablation.A different device was used from the same model to complete the procedure.No patient complications were reported.The device is expected to be returned for analysis.
 
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
The intellanav mifi open-irrigated ablation catheter was selected for use during an ablation procedure to treat atrial fibrillation.It was reported that during procedure they noticed there was a problem with the catheter's irrigation port.It was noted that they rotated the catheter handle a bit too much which broke the irrigation port.The side port was kinking which caused the catheter's temperature to become too high as the pump was unable to irrigate it.A high temperature error had occurred, rising above 35 during the ablation.A different device was used from the same model to complete the procedure.No patient complications were reported.The device was returned for analysis.
 
Manufacturer Narrative
The intellanav mifi open-irrigated ablation catheter was returned to boston scientific for analysis.Visual inspection revealed the irrigation extension tubing was found totally detached/separated from the luer fitting at the adhesive joint, consequently confirming the reported complaint events tubing set damaged/defective, insufficient flow or underinfusion, and temperature cath-poor temperature control - higher than expected.No kink condition was found.
 
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Brand Name
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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 Key16952781
MDR Text Key315460886
Report Number2124215-2023-22874
Device Sequence Number1
Product Code OAD
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0029962858
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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