MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) TRANSSEPTAL NEEDLE, BRK-1, ADULT 18GA., 98CM

Model Number 407207

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208); Pericardial Effusion (3271)

Event Date 02/17/2014

Event Type  Injury  

Event Description

Related mfr reference: 2030404-2014-00026, 3005188751-2014-00029, 3005188751-2014-00030, 3005188751-2014-00031.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.A transesophageal echocardiogram was performed prior to the procedure, revealing no preexisting pericardial effusion.Upon completion of the right atrial geometry, a safire blu ablation catheter was advanced into the left atrium using a fast cath introducer through a patent foramen ovale (pfo).Placement of a second fast cath introducer through the pfo was attempted but was unsuccessful.A transseptal puncture was performed using the second fast cath introducer and a brk transseptal needle.A reflexion spiral ep catheter was advanced into the left atrium and geometry was created without issues.The pt became hypotensive and a pericardial effusion was noted.Protamine was given to reverse the heparin and a pericardiocentesis was performed, which stabilized the pt.The pt was awoken, extubated, and transferred to the icu in stable condition.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.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 info received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is known inherent risk during the use of this device in the heart.

• Brand Name: TRANSSEPTAL NEEDLE, BRK-1, ADULT 18GA., 98CM
• 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: 3692635
• MDR Text Key: 15816828
• Report Number: 3005188751-2014-00028
• 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: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 407207
• Device Lot Number: 4312339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: FAST CATH INTRODUCER (406853/4308468); FAST CATH INTRODUCER (406853/4308468); SAFIRE BLU CATHETER (A088109/4306037); REFLEXION SPIRAL EP CATHETER (402804/4331167)
• Patient Outcome(s): Required Intervention