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

Model Number 87047

Device Problem Material Integrity Problem (2978)

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

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

During an ablation procedure to treat atrial fibrillation and atrial flutter a intellanav mifi open-irrigated catheter was selected for use.It was reported that the irrigation port of the catheter was broken.The catheter was exchanged and the procedure was completed successfully.No patient complications were reported.

Event Description

During an ablation procedure to treat atrial fibrillation and atrial flutter a intellanav mifi open-irrigated catheter was selected for use.It was reported that the irrigation port of the catheter was damaged.The catheter was exchanged and the procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

Visual inspection revealed dried body fluids on the luer tubing and distal end.The adhesive and irrigation tubing were torn open at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.Dried body fluids were found on luer tubing and distal end.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• 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: 10941580
• MDR Text Key: 219382044
• Report Number: 2134265-2020-16889
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (y/n): N
• PMA/PMN Number: P150005/S017
• 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: 12/23/2020

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: 09/04/2021
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0024382985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/23/2020
• Patient Sequence Number: 1