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 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6) years, or older.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 an ablation procedure to treat atrial fibrillation and atrial flutter a intellanav mifi open-irrigated (oi) catheter was selected for it.It was reported that the irrigation port of the catheter was broken.The catheter was replaced with another intellanav mifi oi catheter, and the procedure was completed successfully without patient complications.

Manufacturer Narrative

Age at time of event: 18 years or older.The device was returned to boston scientific for analysis.Visual inspection noted 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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.

Event Description

During an ablation procedure to treat atrial fibrillation and atrial flutter a intellanav mifi open-irrigated (oi) catheter was selected for it.It was reported that the irrigation port of the catheter was broken.The catheter was replaced with another intellanav mifi oi catheter and the procedure was completed successfully without patient complications.

• 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: 10897774
• MDR Text Key: 218244414
• Report Number: 2134265-2020-16389
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0024721495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1