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 Deformation (2976); Material Integrity Problem (2978); Positioning Problem (3009)

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

Event Date 07/19/2019

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 tip damaged occurred.There was an "insulating alteration at the end" of the intellanav mifi open-irrigated ablation catheter.It was also reported that the "kinked appearance of the weighty making the handling difficult." patient complications were not reported.

Event Description

It was reported that tip damaged occurred.There was an "insulating alteration at the end" of the intellanav mifi open-irrigated ablation catheter.It was also reported that the "kinked appearance of the weighty making the handling difficult." patient complications were not reported.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection found that the distal end of the catheter was twisted in a cw rotation, as viewed from the end of the distal tip.Dried body fluid was found on the handle, main shaft and distal end.Dried saline was also found along the distal end and inside several irrigation ports.Tip motion was evaluated against a curve template.The right and left curves failed to reach the specified area on the template.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.X-ray confirmed the twisted distal end.Also found collapsed guide coil inside the shaft.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: 8842883
• MDR Text Key: 152696725
• Report Number: 2134265-2019-08984
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Date Manufacturer Received: 06/24/2020
• Patient Sequence Number: 1