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 Extubate (2402); Pericardial Effusion (3271)

Event Date 03/11/2014

Event Type  Injury  

Event Description

Related manufacturer reference 2030404-2014-00036, 3005188751-2014-00046, 00047, 00048, 00049.During an electrophysiology ablation procedure, a pericardial effusion occurred.A livewire duo-deca ep catheter was placed in the coronary sinus.Two transseptal punctures were made using one brk transseptal needle.A fast cath transseptal introducer and a swartz braided transseptal introducer were then placed in the left atrium.Ablation of the cavotricuspid isthmus was completed with a therapy cool path ablation catheter.A reflexion spiral ep catheter and the therapy cool path ablation catheter were advanced into the left atrium to isolate the pulmonary veins.Upon reentering the right atrium to confirm successful ablation, a pericardial effusion was noted via intracardiac ultrasound.A pericardiocentesis and a pericardial window were performed.The patient was extubated and in stable condition.There were no performance issues noted with any sjm device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation 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 information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation 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 road b; st. paul, MN 55117 ; 6517564071
• MDR Report Key: 3763306
• MDR Text Key: 19973736
• Report Number: 3005188751-2014-00045
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2014

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: 4368709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/04/2014
• 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: (407452/4212014); THERAPY COOL PATH CATHETER (83326/4380920); SWARTZ BRAIDED TRANSSEPTAL INTRODUCER,; FAST CATH TRANSSEPTAL INTRODUCER (406805/4223290); LIVEWIRE DUO-DECA EP CATHETER (401932/4310892); REFLEXION SPIRAL EP CATHETER (D402865/4404211)
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 76