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 Problems Material Perforation (2205); Material Integrity Problem (2978); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

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 hole in the catheter irrigation tubing were noted.During an ablation procedure to treat ventricular tachycardia, an intellanav mifi open-irrigated ablation catheter was selected for use.A high temperature error message was observed on the generator and prevented further ablation attempts.Upon visual examination, a hole in the catheter irrigation tubing was noted.The procedure was completed with another boston scientific catheter of the same model.No patient complications were reported and the patient's current condition is fine.

Manufacturer Narrative

Visual inspection noted that dried body fluid was found on the handle, main shaft and distal end.Dried saline was also found on the distal end and inside several irrigation ports.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.A device history record review was performed and no deviation was found.No manufacturing related observations were discovered during returned device analysis.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.

Event Description

It was reported that hole in the catheter irrigation tubing were noted.During an ablation procedure to treat ventricular tachycardia, an intellanav mifi open-irrigated ablation catheter was selected for use.A high temperature error message was observed on the generator and prevented further ablation attempts.Upon visual examination, a hole in the catheter irrigation tubing was noted.The procedure was completed with another boston scientific catheter of the same model.No patient complications were reported and the patient's current condition is fine.

• 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: 9873298
• MDR Text Key: 184805844
• Report Number: 2134265-2020-03765
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0024773490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Date Manufacturer Received: 06/08/2020
• Patient Sequence Number: 1