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

Model Number 87048

Device Problem Failure to Deliver Energy (1211)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 xp temperature ablation catheter was used in a right atrial flutter ablation procedure.The catheter could not create a lesion with a power of 70 watts on the isthmus.The procedure was canceled due to this event.No patient complications were reported.The device has been returned for analysis.

Event Description

It was reported that a intellanav mifi xp temperature ablation catheter was used in a right atrial flutter ablation procedure.The catheter could not create a lesion with a power of 70 watts on the isthmus.The procedure was canceled due to this event.No patient complications were reported.The device has been returned for analysis.

Manufacturer Narrative

Initial reporter phone: (b)(6).Device technical analysis visual inspection of the device did not show obvious visible defects.Bodily fluids were noted on the handle and the tip.During functional testing of the returned device the tension control knob functioned properly on both lock and unlock positions.During electrical testing no electrical opens or shorts as checked manually using a multi-meter and breakout box.However during the bench soak test multiple electrodes having open values.During ablation testing the device functioned normally through three 2-minute ablations in the straight, right curve and left curve positions.Power, temperature and impedance measurements were as expected.Micro crack in the mini electrode collar were noted.

• Brand Name: INTELLANAV MIFI XP TEMPERATURE 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: 11651115
• MDR Text Key: 244970639
• Report Number: 2134265-2021-04719
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: 87048
• Device Catalogue Number: 87048
• Device Lot Number: 0026447523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Date Manufacturer Received: 05/05/2021
• Patient Sequence Number: 1