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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Same case as 2134265-2018-60619.It was reported a perforation and pericardial effusion occurred.An intellamap orion mapping catheter and an intellatip mifi oi ablation catheter were selected for use during a paroxysmal atrial fibrillation ablation procedure.It was planned to perform right pulmonary vein (rpv) isolation from left pulmonary vein (lpv) isolation.When the transition to rpv isolation was performed following lpv isolation, the a pressure decreased.Echocardiography confirmed pericardial effusion and a pericardial drainage was performed.Red blood cell (rbc) and fresh frozen plasma (ffp) transfusions were performed, but did not stop the bleeding; therefore, surgical intervention took place.A hole was found in the left superior pulmonary vein (lspv) ante.The patient was getting better and recovering.There had been no device issues during the procedure.The perforation and effusion were "likely" due to excessive ablation.
Event or Problem Description
Same case as 2134265-2018-60619.It was reported a perforation and pericardial effusion occurred.An intellamap orion mapping catheter and an intellatip mifi oi ablation catheter were selected for use during a paroxysmal atrial fibrillation ablation procedure.It was planned to perform right pulmonary vein (rpv) isolation from left pulmonary vein (lpv) isolation.When the transition to rpv isolation was performed following lpv isolation, the a pressure decreased.Echocardiography confirmed pericardial effusion and a pericardial drainage was performed.Red blood cell (rbc) and fresh frozen plasma (ffp) transfusions were performed, but did not stop the bleeding; therefore, surgical intervention took place.A hole was found in the left superior pulmonary vein (lspv) ante.The patient was getting better and recovering.There had been no device issues during the procedure.The perforation and effusion were "likely" due to excessive ablation.Additional information received reported that the ablation catheter and another manufacturer's ring catheter were inside the patient when the adverse event occurred.Both the ablation catheter and the ring catheter were used with other manufacturers' sheaths.No resistance was felt while manipulating the orion.The device was returned for analysis.The distal end had a slight curve to the left after the steering knob was returned to neutral.The device passed the curve test.Continuity checks revealed no electrical opens or shorts; all electrodes, sensor, and thermocouple resistance measurements were within specification.The steering knob and the tension control knob functioned properly on both the lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.The device passed all electrical testing/inspection and no error codes, warnings, or alarms occurred ablation testing.

• 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; dc a330,; saint paul MN 55112
• MDR Report Key: 7841461
• Report Number: 2134265-2018-60618
• Device Sequence Number: 13949804
• 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,Followup
• Report Date (Section B): 10/02/2018

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: 06/28/2021
• Device Model Number: M004PM96200
• Device Catalogue Number: 86493
• Device Lot Number: 0022317356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/02/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RING CATHETER: J. CATH LIBERO; SHEATH: ABBOTT AGILIS; SHEATH: ABBOTT SL0
• Outcome Attributed to Adverse Event: Required Intervention