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

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

Patient Problems Cardiac Perforation (2513); Vascular Dissection (3160)

Event Type  Injury  

Event Description

The following was published in the journal of cardiovascular development and disease 9.3 (mar 7, 2022)."idiopathic ventricular arrhythmias originating from different portions of the coronary venous system: prevalence, electrocardiographic characteristics, catheter ablation, and complications", dr.Wang, yaoji.Two patients suffered from coronary vein rupture, which induced a pericardial tamponade in one patient and pericardial effusion in one patient, managed successfully by pericardiocentesis.Two cases were diagnosed with coronary spasms and succeed to respond to nitroglycerin (st-segment was elevated nearly back to normal the following day).Another case in the lad was managed unsuccessfully using nitroglycerin.Coronary vein dissection occurred in ten patients.

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 events remain unknown.

• Brand Name: INQUIRY¿ FIXED CURVE 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14020672
• MDR Text Key: 288655457
• Report Number: 2030404-2022-00029
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K946333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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: 03/28/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 04/24/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other