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	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient experienced a pericardial effusion.An ablation procedure was being performed for atrioventricular reciprocating tachycardia (avrt).After the electrophysiology (ep) study was performed and a left lateral pathway was found, the physician used a blazer prime htd to ablate the pathway.They did not have success and felt he couldn't reach far enough and withdraw the catheter to check the mechanism.On removal of the catheter, the physician showed that the deflector mechanisms of the blazer prime htd was not working.The catheter's deflection mechanism was faulty; it did not deflect.A new blazer open-irrigated catheter was inserted and the procedure continued.They continued the procedure and a block was achieved.The physician then noted that the patient's blood pressure (bp) had dropped and pulse rate increased.They performed a cardiac ultrasound and found a large pericardial effusion, which was drained.The patient was discharged to intensive care unit (icu) with a pericardial drain in place and was in the icu overnight.She was in hospital until the (b)(6) 2019, when she was discharged home.The pericardial effusion resolved and patient was in sinus rhythm.It was reported that they had no way of knowing at exactly what time the pericardial effusion started; but it wasn't there at the start of the procedure.There was also a dynamic xt catheter and two viking electrode catheters in the body at the time.It was unknown which catheter(s) caused or contributed to the adverse events.

• Brand Name: VIKING
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9363920
• Report Number: 2134265-2019-14350
• Device Sequence Number: 16701937
• Product Code: DRF
• UDI-Device Identifier: 08714729878476
• UDI-Public: 08714729878476
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 11/22/2019

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: 02/17/2021
• Device Model Number: 87070
• Device Catalogue Number: 87070
• Device Lot Number: 0023361446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/22/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLAZER OPEN-IRRIGATED; BLAZER PRIME; DYNAMIC XT; VIKING ELECTRODE CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention