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

Model Number M004PMR9620K20

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)

Event Date 02/20/2019

Event Type  Injury  

Event Description

It was reported that a cardiac perforation was experienced.During an ablation procedure in the left atrium with an intellanav mifi open-irrigated, two error codes were encountered when attempting to utilize the catheter.First was code 1405-2: magnetic tracking issue.The second error code was 1319-2: magnetic localization system internal error.The catheter was replaced with another intellanav mifi open-irrigated and the error codes were resolved.The ablation was almost finished with a non-bsc coronary sinus (cs) catheter and the intellanav mifi open-irrigated catheter located at the roof of the left atrium when it was noticed that the patient's blood pressure was low.The physician did not mention any resistance with the ablation catheter, but stated that he was putting a lot of torque on the catheter.The physician is unsure if the perforation was caused by the bsc catheter but is likely caused by the ablation catheter.The patient was sent to surgery to close the perforation.The patient is currently stable and doing fine.It was noted that the tracking issues encountered with the first catheter did not contribute to the perforation.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 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: 8398882
• MDR Text Key: 138089780
• Report Number: 2134265-2019-02183
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2020
• Device Model Number: M004PMR9620K20
• Device Catalogue Number: 87047
• Device Lot Number: 22397518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATED; SHEATH: 45 LAMP; SHEATH: 90 LAMP
• Patient Outcome(s): Required Intervention