MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) TRANSSEPTAL NEEDLE BRK SERIES, ADULT 18 GA, 71CM

Model Number 407200

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

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

Event Date 03/21/2014

Event Type  Injury  

Event Description

Related manufacturer ref 2030404-2014-00045, 3008452825-2014-00012, 3005188751-2014-00063, 3005188751-2014-00064, 3005188751-2014-00065, 3005188751-2014-00066.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, an 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.

Manufacturer Narrative

The results of the investigations are inconclusive since the device was not returned for analysis.Our analysis was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the info received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac peroration is an inherent risk during the use of this device in the heart.

• Brand Name: TRANSSEPTAL NEEDLE BRK SERIES, ADULT 18 GA, 71CM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 177 east country rd b; st. paul, MN 55117 ; 6517564071
• MDR Report Key: 3784134
• MDR Text Key: 4431283
• Report Number: 3005188751-2014-00067
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072278
• 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 Expiration Date: 11/30/2016
• Device Model Number: 407200
• Device Lot Number: 4368664
• 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
• Date Device Manufactured: 12/01/2013
• 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: REFLEXION SPIRAL EP CATHETER (402804/UNK); TACTICATH QUARTZ ABLATION CATHETER; (407356/4369928); (PN-(B)(4)/25592); INQUIRY AFOCUS II EP CATHETER (87008/4407706); AGILIS NXT INTRODUCER (408310/4342988); SUPREME EP QUADRIPOLAR CATHETER (401430/4402149); SWARTZ BRAIDED TRANSSEPTAL INTRODUCER; INQUIRY EP DECAPOLAR CATHETER (81104/4237621)
• Patient Outcome(s): Required Intervention