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

Model Number 407200

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Tachycardia (2095); Pericardial Effusion (3271)

Event Date 02/24/2014

Event Type  Injury  

Event Description

Related manufacturer reference: 2030404-2014-00030, 3005188751-2014-00036, 00038, 00039.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.A livewire duo-deca ep catheter was placed in the coronary sinus as a positional reference.An agilis nxt introducer, a sl1 introducer, and a non-sjm ice catheter were advanced into the right atrium.Two brk transseptal needles were used to perform two transseptal punctures, after which a non-sjm lasso catheter was placed in the left atrium to assist in geometry creation with the ensite navx system.After the geometry was completed, a safire blu duo ablation catheter was used to perform ablation around the pulmonary veins.While ablating in the septal region anterior to the right pulmonary veins, an increase in heart rate was noted.The non-sjm ice catheter revealed a pericardial effusion.A pericardiocentesis was performed; however, due to continued active bleeding, the pt was transferred to a surgery center for successful repair of an intra-atrial perforation.The physician alleged 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 lot number was unavailable.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known inherent risk during the use of this device in the heart.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71 CM
• 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: 3738604
• MDR Text Key: 4278788
• Report Number: 3005188751-2014-00040
• 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: 02/24/2014

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: 407200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/21/2014
• 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: AGILIS NXT INTRODUCER (308410/LOT UNK); LIVEWIRE DUO DECA EP CATHETER(401932/ LOT UNK); SL1 INTRODUCER (MODEL/LOT UNK); BRK TRANSSEPTAL NEEDLE (407206/LOT UNK); SAFIRE BLU DUO ABLATION CATHERER,; ENSITE NAVX SYSTEM; (A088107/LOT 4306088); BIOSENSE WEBSTER LASSO CATHETER(MODEL/LOT UNK); BIOSENSE/SIEMENS ICE CATHETER(MODEL/LOT UNK)
• Patient Outcome(s): Required Intervention