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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 Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
Event Type  malfunction  
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
It was reported that a intellanav mifi open-irrigated ablation catheter was used in a atrial fibrillation (af) ablation procedure.During treatment the temperature limit began to be applied midway, and the energization was forcibly stopped.The catheter was removed and checked, it was noted the three-way stopcock connection part of the ablation catheter side was found to be torn.The catheter was replaced and the procedure was completed without patient complications.
 
Manufacturer Narrative
Visual examination of the returned device revealed the irrigation luer was torn off at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.Dried body fluid found on the luer tube, shaft and the distal end.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that a intellanav mifi open-irrigated ablation catheter was used in a atrial fibrillation (af) ablation procedure.During treatment the temperature limit began to be applied midway, and the energization was forcibly stopped.The catheter was removed and checked, it was noted the three-way stopcock connection part of the ablation catheter side was found to be torn.The catheter was replaced and the procedure was completed without patient complications.
 
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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
MDR Report Key11050268
MDR Text Key223053935
Report Number2134265-2020-18283
Device Sequence Number1
Product Code OAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2021
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0024597969
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Date Manufacturer Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
Patient Weight65
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