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

Model Number	M004PM96200
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pericardial Effusion (3271)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
Same case as 2134265-2018-62779.It was reported a pericardial effusion and cardiac arrest occurred.An intellatip mifi oi ablation catheter and an intellamap orion mapping catheter were selected for use during a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation.It was reported blood pressure slightly decreased; an echo examination was performed and pericardial fluid had accumulated.While performing a pericardial puncture to remove the fluid, cardiac arrest occurred and percutaneous cardiopulmonary support (pcps) was performed.Cardiac arrest lasted approximately 7 minutes.Thoracotomy was also performed.Additional information received reported that the patient's heart was beating and pcps was removed from the patient; the patient was awakening and no subsequent complications were observed.The procedure had not been completed.It had also been noted that the tracking location of the ablation catheter was incorrect on the rhythmia screen.However, it was reported the event was not a device issue and the physician did not believe the effusion was due to the catheters.Blood leaked from the left ventricle; however, neither catheter had been approached to the left ventricle.No resistance had been felt while maneuvering the catheters.

• Brand Name: INTELLATIP MIFI OPEN-IRRIGATED
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8069562
• Report Number: 2134265-2018-62781
• Device Sequence Number: 1658258
• Product Code: OAD
• UDI-Device Identifier: 08714729848684
• UDI-Public: 08714729848684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005/S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: M004PM96200
• Device Catalogue Number: 86493
• Device Lot Number: 0022305067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/14/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: BOSTON SCIENTIFIC ZURPAZ 8.5F
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention