MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLANAV OI

Model Number	M004R9620K20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); ST Segment Elevation (2059)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; 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.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
Same case as mdr id# 2134265-2018-01569 and 2134265-2018-01566.It was reported an air bubble was introduced into the patient¿s heart.An intellanav mifi xp ablation catheter was selected for use during an atrial fibrillation procedure.However, the area of the heart that was being treated was a low blood flow area which equated to low power delivery; to resolve this issue the physician switched to an irrigated catheter and selected an intellanav oi with a metriq irrigation pump and tubing set.The catheter was prepped and flushed with nearly 80ml through the pump.Almost immediately after ablation began, the maestro 4000 generator halted and displayed an error message.In an effort to troubleshoot the error message, the catheter was replaced with another intellanav oi.The second catheter was flushed with the pump for approximately 50ml of saline.However, the issue persisted.The catheter was removed from the patient, the pump was powered off, and the cable between the pump and generator was replaced which resolved the issue.Power was turned back on, the purge button was held down for a few seconds, standby flow mode was selected at 2ml/min, and the pump was deemed to be functioning appropriately.The physician then inserted the catheter back into the patient.Shortly after coming on ablation, an air bubble was visualized on fluoroscopy entering the patient¿s heart.It was noted that the bubble detector had not alarmed; however, it was not reported whether the bubble had gone undetected by the bubble detector, or if the bubble had been purged distal to the bubble detector.The left ventricle immediately paused for a couple seconds and then regained movement.St elevation was then noticed on ecg.The physician immediately called for an interventional cardiologist to perform a heart cath.The interventionist contrasted both the left and right coronary arteries.After examination, both were determined to be clear of obstruction / occlusion.The physician then monitored the patient until heart rhythm was back in sinus rhythm and the 12-lead ecg was similar to when the case started.After patient work up, both the ep physician and the anesthesia nurse performed a quick neuro function test; the patient was able to respond to requests verbally, grip both hands, and wiggle both feed.The patient left the room in stable condition to be monitored overnight.

• Brand Name: INTELLANAV OI
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7315939
• Report Number: 2134265-2018-01570
• Device Sequence Number: 104933
• Product Code: OAD
• UDI-Device Identifier: 08714729937449
• UDI-Public: 08714729937449
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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: 11/28/2020
• Device Model Number: M004R9620K20
• Device Catalogue Number: R9620K2
• Device Lot Number: 21449042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention