MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIKING; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	87070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969); Pericardial Effusion (3271)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.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 or Problem Description
It was reported that a radiofrequency (rf) ablation with a viking electrode catheter and an intellanav mifi open-irrigated via a 8f sheath was being performed to treat premature ventricular contractions.The physician performed ablation after 3d mapping.The physician found the mapping position had shifted, but the system did not alert an error.About fifteen minutes into ablation, the patient experienced a pericardial effusion near the left aorto-mitral continuity (amc) origin, so the physician stopped the ablation.The physician then performed a pericardiocentesis.The patient was transferred to the coronary care unit (ccu) for further observation after they were stabilized.However, the patient died on (b)(6) 2020 due to condition deterioration.The patient's official cause of death was acute myocardial infarction.The devices are expected to be returned.It was reported that the mapping position shift did not cause or contribute to the pericardial effusion and subsequent death.No resistance was felt while maneuvering the catheters.
Event or Problem Description
It was reported that a radiofrequency (rf) ablation with a viking electrode catheter and an intellanav mifi open-irrigated via a 8f sheath was being performed to treat premature ventricular contractions.The physician performed ablation after 3d mapping.The physician found the mapping position had shifted, but the system did not alert an error.About fifteen minutes into ablation, the patient experienced a pericardial effusion near the left aorto-mitral continuity (amc) origin, so the physician stopped the ablation.The physician then performed a pericardiocentesis.The patient was transferred to the coronary care unit (ccu) for further observation after they were stabilized.However, the patient died on (b)(6) 2020 due to condition deterioration.The patient's official cause of death was acute myocardial infarction.The devices are expected to be returned.It was reported that the mapping position shift did not cause or contribute to the pericardial effusion and subsequent death.No resistance was felt while maneuvering the catheters.It was further reported that an updated stamped statement was received from the hospital stating that "the direct cause of pericardial effusion & death are not related with bsc viking electrode catheter and intellanav mifi oi catheter used in radiofrequency (rf) ablation.".
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.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.

• Brand Name: VIKING
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10781456
• Report Number: 2134265-2020-15256
• Device Sequence Number: 13734759
• Product Code: DRF
• UDI-Device Identifier: 08714729878100
• UDI-Public: 08714729878100
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971265
• 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): 11/05/2020

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: 01/21/2022
• Device Model Number: 87070
• Device Catalogue Number: 87070
• Device Lot Number: 0025085895
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLANAV MIFI OPEN IRRIGATED CATHETER; INTELLANAV MIFI OPEN IRRIGATED CATHETER
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 59 YR