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); Positioning Problem (3009)

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

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

Event is reportable based on device analysis completed.Visual inspection revealed the sheath of the catheter was torn, exposing guide coil and wires were visible in the distal end.Dried saline was found in the luer, on the handle, shaft and tip.Dried body fluids was also noted on the handle.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.Both right and left curves were 180 degrees out of plane.The complaint investigation conclusion code is design inadequate for purpose.

Event Description

Reportable based on device analysis completed on 10/08/2020.During an ablation procedure a intellanav mifi open-irrigated ablation catheter was selected for use.It was reported that the catheter shaft did not bend or curve.The catheter was removed from the patient and replaced with another catheter of the same model.The procedure was completed successfully without any patient complications.However, device analysis revealed torn catheter tubing on the distal end with exposing wires.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10792886
• MDR Text Key: 214809643
• Report Number: 2134265-2020-15392
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2022
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0025075594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1