MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 87047

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

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

During an ablation procedure an intellanav mifi open-irrigated ablation catheter was selected for use.It was reported that blood was flowing backwards into the irrigation port during ablation in the left atrium.The catheter was exchanged and the procedure was completed without any patient complications.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection noted 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 was also found on the handle.Electrical continuity checks revealed no electrical opens or shorts, all electrode/ thermocouple/magnetic sensor resistances measured in specifications and were typical.The steering knob and the tension control knob functioned properly on both lock and unlock positions.There is no evidence to suggest that this device was used in a manner inconsistent with the labeled indications.No abnormal resistance was felt when actuating the steering mechanism.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

During an ablation procedure an intellanav mifi open-irrigated ablation catheter was selected for use.It was reported that blood was flowing backwards into the irrigation port during ablation in the left atrium.The catheter was exchanged and the procedure was completed without any patient complications.

• 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 Key: 11272818
• MDR Text Key: 230079474
• Report Number: 2134265-2021-01173
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0025232010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 04/02/2021
• Patient Sequence Number: 1
• Patient Age: 60 YR