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 Device Displays Incorrect Message (2591); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

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

During a pulmonary vein isolation de novo procedure a intellanav mifi open-irrigated ablation catheter was selected for use.During ablation on the septal part of the right sided veins the ablation generator produced a high temperature warning.The catheter was inspected and the irrigation part of the catheter handle broke off.The procedure was completed with another intellanav mifi open-irrigated ablation catheter, however with the replacement catheter was connected a error "1312: high noise detected." was displated and noise on all ic channels and surface ecg occurred.An exchanged cable didn't solve issue, changing catheter solved this issue.

Event Description

During a pulmonary vein isolation de novo procedure a intellanav mifi open-irrigated ablation catheter was selected for use.During ablation on the septal part of the right sided veins the ablation generator produced a high temperature warning.The catheter was inspected and the irrigation part of the catheter handle broke off.The procedure was completed with another intellanav mifi open-irrigated ablation catheter, however with the replacement catheter was connected a error "1312: high noise detected." was displayed and noise on all ic channels and surface ecg occurred.An exchanged cable didn't solve issue, changing catheter solved this issue.

Manufacturer Narrative

Visual inspection revealed that the adhesive and irrigation tubing were torn open at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.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.

• 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: 10750027
• MDR Text Key: 213664353
• Report Number: 2134265-2020-14939
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0025212066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/22/2020
• Patient Sequence Number: 1