MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(AF-IRVINE) INQUIRY? DECAPOLAR ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number 81107

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Complaint, Ill-Defined (2331)

Event Date 09/27/2014

Event Type  Injury  

Event Description

Related manufacturer reference 2030404-2014-00094, 2030404-2014-00095, 3005188751-2014-00125, 3005188751-2014-00126.During a pulmonary vein isolation procedure, a cardiac tamponade occurred.An inquiry ep catheter was advanced into the coronary sinus.Transseptal puncture was performed with a brk transseptal needle and a therapy cool flex ablation catheter was advanced through an agilis nxt introducer to the left atrium.The patient was restless during the procedure and, after approximately two hours, became increasingly hypotensive and an echocardiogram revealed a cardiac tamponade.A pericardiocentesis was then performed, which stabilized the patient.There were no performance issues with any sjm device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• Brand Name: INQUIRY? DECAPOLAR ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(AF-IRVINE); 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4197379
• MDR Text Key: 21178124
• Report Number: 2030404-2014-00096
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK961942
• 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
• Report Date: 09/27/2014

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
• Device Model Number: 81107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2014
• Initial Date FDA Received: 10/23/2014
• 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
• Treatment: INQUIRY OPTIMA EP CATHETER; AGILIS NXT INTRODUCER; THERAPY COOL FLEX ABLATION CATHETER; BRK TRANSSEPTAL NEEDLE; ENSITE VELOCITY MAPPING SYSTEM; BIOSENSE WEBSTER STOCKERT GENERATOR; SENSITHERM ESOPHAGEAL TEMPERATURE PROBE
• Patient Outcome(s): Required Intervention
• Patient Weight: 120