Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Improper Flow or Infusion (2954)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
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 procedure.During ablation it was that the impedance gradually increased and was stopped at about 10 seconds.The catheter was removed from the patient and was flushing was performed with a high flow of 60 ml.It was noticed during the flushing that saline coming from the irrigation holes at the catheter tip is slightly slow.The catheter was replaced and the procedure was completed without patient complications.
 
Manufacturer Narrative
Visual inspection of the device showed dried saline on the distal end and attached to the inner wall of the irrigation tubing inside the luer fitting.Dried body fluid found on the handle, main body tubing and on the distal end.Electrical continuity checks revealed no electrical opens or shorts, as checked manually using a multi-meter and breakout box.All electrodes, sensor and thermocouple resistances measured in spec and were typical.During functional testing the steering knob and the tension control knob functioned properly on both lock and unlock positions.The device's lumen was leak tested, pressure decay values were 0.1048 psi, 0.0822 psi, and 0.0668 psi.These values are within an acceptable limit.The device was connected to a metriq pump to purge saline for approximately 30 seconds and verify all ports were functioning.The distal tip electrode was immersed in 0.45% saline for 30 minutes.Tc+ and tc- to tip resistance measurements remained open.Next, the device was connected to a metriq pump.After irrigating for approximately 30 minutes at a flow rate of 30 ml/min, tc+ and tc- to tip resistance measurements remained open.A metriq pump was connected to the device and the distal end was suspended in the center of a 250ml beaker during the purge function and saline appear to be coming out of all ports as expected.Then changed metriq pump flow rate to 30ml/min (ablation rate), and after 5 minutes the empty beaker contained approximately 150 ml of saline, which was within specifications.The device was connected to a maestro generator, rhythmia hdx system.Impedance readings were normal.Three 120 second, 50w ablations were performed.All three ablations (straight, right & left curve) were normal with no error codes or warnings.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 procedure.During ablation it was that the impedance gradually increased and was stopped at about 10 seconds.The catheter was removed from the patient and was flushing was performed with a high flow of 60 ml.It was noticed during the flushing that saline coming from the irrigation holes at the catheter tip is slightly slow.The catheter was replaced and the procedure was completed without patient complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11051041
MDR Text Key223053436
Report Number2134265-2020-18291
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 03/22/2021
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 Date11/28/2021
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0024850160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Date Manufacturer Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
-
-