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	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: early 60's.(b)(4).
Event or Problem Description
Same case as 2134265-2018-02371.It was reported st elevation and a likely air embolism occurred.During ablation with an intellanav oi ablation catheter, the bubble detector on the metriq pump alarmed.The bubble was addressed by stopping ablation, removing the catheter from the body, dislodging any bubbles in the pump tubing, and flushing the catheter with 75 ml.The pump was then placed in standby flow and reinserted into the body.The physician noticed st elevation and a drop in blood pressure; it was unclear if this occurred before or during initial ablation.The physician indicated it was likely an air embolism.The patient was examined using ultrasound, but no further interventions took place.The catheter was removed from the patient and exchanged for another boston scientific ablation catheter.The case ended successfully and the patient left the room in stable condition.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned device passed all electrical testing; continuity checks revealed no electrical opens or shorts, and all electrode, thermocouple, and sensor resistance measurements were within specification.The steering knob and tension control knob functioned properly in both the lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Ablation was verified using a maestro generator, metriq pump, and a tank of saline (37 degrees celsius).Three ablation tests were performed and no error codes or alarms occurred; the device was found to be within specification.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.Updated: device evaluated by mfr.; eval summary attached; method codes, result codes, conclusion codes.Bsc id a00710019 / tw5080107.
Event or Problem Description
Same case as 2134265-2018-02371.It was reported st elevation and a likely air embolism occurred.During ablation with an intellanav oi ablation catheter, the bubble detector on the metriq pump alarmed.The bubble was addressed by stopping ablation, removing the catheter from the body, dislodging any bubbles in the pump tubing, and flushing the catheter with 75ml.The pump was then placed in standby flow and reinserted into the body.The physician noticed st elevation and a drop in blood pressure; it was unclear if this occurred before or during initial ablation.The physician indicated it was likely an air embolism.The patient was examined using ultrasound, but no further interventions took place.The catheter was removed from the patient and exchanged for another boston scientific ablation catheter.The case ended successfully and the patient left the room in stable condition.

• 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: 7372812
• Report Number: 2134265-2018-02370
• Device Sequence Number: 19221535
• Product Code: OAE
• 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,Followup
• Report Date (Section B): 03/05/2018

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: 01/22/2021
• Device Model Number: M004R9620K20
• Device Catalogue Number: R9620K2
• Device Lot Number: 0021647452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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: Other