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 Problem Device Displays Incorrect Message (2591)

Patient Problems Atrial Fibrillation (1729); Unspecified Infection (1930); Thrombosis (2100)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

Event Description

(b)(6) clinical study.It was reported that the patient experienced suspected thrombophlebitis with new onset of atrial fibrillation (af).On (b)(6) 2019, during an ablation procedure treat af, the intellanav mifi open-irrigated ablation catheter had a broken sensor, and the catheter not always visible.They exchanged it for a new one.Then on (b)(6) 2019, after the procedure, the patient had an infection with a recurrence of an "at." the devices used during the procedure were two intellanav mifi open-irrigated ablation catheters, an intellamap orion catheter and a zurpaz 8.5 f sheath.The cause was not known.The patient was given an intravenous (iv) medication change on (b)(6) 2019.On (b)(6) 2019, the patient was given amoxicillin.The outcome was unknown.

• 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: 9563722
• MDR Text Key: 175280073
• Report Number: 2134265-2020-00027
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2021
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0023811344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 97