MAUDE Adverse Event Report: ST JUDE MEDICAL, INC (AF-IRVINE) INQUIRY AFOCUSII, 1120-7-4-SM-AF20DL CATHETER

Model Number 87008

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452); Pericardial Effusion (3271)

Event Date 03/21/2014

Event Type  Injury  

Event Description

Related mfr ref: 3008452825-2014-00012, 305188751-2014-00063; 00064; 00065; 00066; and 00067.Following an atrial fibrillation procedure, a pericardial effusion occurred.Two transseptal punctures were performed with a brk transseptal needle and a swartz braided transseptal introducer and an agilis nxt introducer were advanced into the left atrium.An inquiry decapolar ep catheter was placed in the coronary sinus.A reflexion spiral ep catheter, and inquiry afocus ii ep catheter, and a tacticath ablation catheter were all used in the left atrium for mapping and ablation.Left and right wide area circumferential ablation (waca) were successfully performed around the pulmonary veins.The pt developed transient hypotension during the right waca but blood pressure returned to normal immediately.The procedure was completed and the pt converted to sinus rhythm.After the procedure, the pt became hypotensive and diaphoretic and an echocardiogram revealed a pericardial effusion a pericardiocentesis was performed, which stabilized the pt.The pt was discharged home a few days later and remained in sinus rhythm.There were no performances issues with any sjm device.

• Brand Name: INQUIRY AFOCUSII, 1120-7-4-SM-AF20DL CATHETER
• Manufacturer (Section D): ST JUDE MEDICAL, INC (AF-IRVINE); irvine CA
• Manufacturer Contact: denise johnson, rn ; 177 e county rd b; st paul, MN 55117 ; 6517564470
• MDR Report Key: 3784143
• MDR Text Key: 4443543
• Report Number: 2030404-2014-00045
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042775
• 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: 03/26/2014

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: 87008
• Device Lot Number: 4407706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/22/2014
• 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: SUPREME EP QUADRIPOLAR CATHETER (401430/4402149); (407356/4369928); (PN-004-065/25592); INQUIRY EP DECAPOLAR CATHETER (81104/4237621); BRK TRANSSEPTAL NEEDLE (407200/4368664); REFLEXION SPRIAL EP CATHETER (402804/UNK); TACTICATH QUARTZ ABLATION CATHETER,; AGILIS NXT INTRODUCER (408310/4342988); SWARTZ BRAIDED TRANSSEPTAL INTRODUCER,
• Patient Outcome(s): Required Intervention