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 Stroke/CVA (1770); Cardiac Perforation (2513); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

No product was returned for investigation.A review of the device history record was not possible since the batch number is unavailable.Based on the information provided to abbott, the reported adverse events could not be confirmed.Per the ifu, cardiac perforation is a known risk during the use of this device.Further information regarding the event were requested but not received.

Event Description

Related manufacturer reference: 2030404-2019-00090.The following was published in european pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the european society of cardiology in an article titled ¿multicentre safety of adding focal impulse and rotor modulation (firm) to conventional ablation for atrial fibrillation" by baykaner t, schricker aa, et al, 2017; 19(5):769-774.  two patients had a stroke or transient ischaemic attack, 9 patients had tamponade or a pericardial drain occur, 2 patients had heart block, 1 patient had myocardial infarction.(doi:10.1093/europace/euw377).

• 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.(AF-IRVINE); 2375 morse ave; irvine CA 92614
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8974932
• MDR Text Key: 156909494
• Report Number: 2030404-2019-00091
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/09/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/09/2019
• 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): Other