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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 87047
Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2020
Event Type  malfunction  
Event Description
It was reported that a intellanav mifi open-irrigated was used in a atrial fibrillation ablation procedure.During ablation the generator gave a high temperature error.The catheter was removed from the patient and coagulate was noted at the tip of the catheter.During trouble shooting the catheter was flash flushed and a puddle was noted at the catheter handle due to crack in the hub.The catheter was replaced and the procedure was completed with no patient complications being reported.
 
Manufacturer Narrative
Visual inspection of the device showed that the irrigation tubing had a tear at the proximal side of the adhesive joint securing the leur fitting.Dried body fluids were also noted on the leur, sheath, distal end and irrigation tubing.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 was used in a atrial fibrillation ablation procedure.During ablation the generator gave a high temperature error.The catheter was removed from the patient and coagulate was noted at the tip of the catheter.During trouble shooting the catheter was flash flushed and a puddle was noted at the catheter handle due to crack in the hub.The catheter was replaced and the procedure was completed with no patient complications being reported.
 
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Brand Name
INTELLANAV MIFI OPEN-IRRIGATED
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 Key10567430
MDR Text Key207948141
Report Number2134265-2020-13127
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729938361
UDI-Public08714729938361
Combination Product (y/n)N
PMA/PMN Number
P150005/S017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/09/2022
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0025020445
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2020
Date Manufacturer Received01/25/2021
Patient Sequence Number1
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