MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER; ELECTRODE RECORDING CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130); Cardiac Perforation (2513); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported pericardial effusion and coronary artery spasm could not be conclusively determined.

Event Description

Related manufacturing reference: 3005334138-2019-00471.The following was published in hearthrhythm case report in an article titled "severe coronary artery spasm repeatedly induced after left pulmonary vein isolation in patient with atrial fibrillation" by honda n, takase s, et al.2018;4(11)501-505.Https://doi.Org/10.1016/j.Hrcr.2018.07.010."during a case of paroxysmal atrial fibrillation (paf) and atrial flutter a pericardial effusion and coronary artery spasm (cas) occurred.Following transseptal access, pulmonary vein isolation (pvi) ablation was started with the left pvs first.When the left pvs were completed, an optima catheter was inserted into the left sided pvs for confirmation, however; the patient became bradycardic (30 bpm) due to complete atrioventricular (av) block with st-segment elevation and ventricular fibrillation accompanied by reciprocal st-segment depression.The patient was also hypotensive at this time.Treatment was started with administration of isotonic sodium chloride and ventricular pacing to support the heart rate.Intracardiac echocardiography confirmed a pericardial effusion and coronary angiography via the right femoral artery confirmed bilateral coronary artery flow and coronary obstruction due to spasm from segment 2 to segment 4 of the in the right coronary artery.Cas improved following an injection of nicorandil, sinus rhythm and blood pressure also normalized so the procedure was continued.When the optima catheter was inserted for the right sided pvi ablation, under iv infusion of nicorandil, the st-segment elevation, vf and av block recurred.Multiple injections of nicorandil into the coronary artery to terminate the cas was attempted but unsuccessful.When direct infusion of system nicorandil did not resolve the cas the ablation procedure was ended.In 6 month follow up the cas had not recurred.There were no performance issues with any abbott device however the user believes the contact of the optima catheter in the left atrium after left gp ablation may have contributed to the cas.".

• Brand Name: INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8942256
• MDR Text Key: 158870073
• Report Number: 2030404-2019-00085
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR