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 Hemothorax (1896); Low Blood Pressure/ Hypotension (1914); Thrombus (2101); Pericardial Effusion (3271)

Event Date 04/07/2014

Event Type  Injury  

Event Description

During an atrial fibrillation ablation procedure using a brk transseptal needle, a pericardial effusion occurred.After several attempts at a transseptal puncture with a brk transseptal needle, the pt became hypotensive.An echocardiogram was performed, which revealed a small pericardial effusion.A chest x-ray was also performed, which revealed a left hemothorax.A chest tube was placed and the pt was sent to the icu in stable condition.Throughout the day, the pt became increasingly hypotensive and it was thought the pt may have experienced a myocardial infarction (mi).The pt was taken to the cardiac catheterization lab for an angiogram, which revealed the pt was negative for mi.A transesophageal echocardiogram was performed, which revealed a small pericardial effusion, which was unchanged from earlier in the day.The pt was transferred to the operating room for a pericardial window procedure and a clot was removed from the pericardial space.The pt's blood pressure improved and the pt stabilized.There were no performance issues with any sjm device during the ablation procedure.

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 mfr 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 was procedure related.Per the ifu, cardiac perforation is an inherent risk during the transseptal technique.

• 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: 3779080
• MDR Text Key: 4445971
• Report Number: 3005188751-2014-00060
• 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: 04/07/2014

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: 06/30/2016
• Device Model Number: 407200
• Device Lot Number: 4134183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: SWARTZ BRAIDED TRANSSEPTAL INTRODUCER; LIVEWIRE EP OCTAPOLAR CATHETER (401652/4312520); LIVEWIRE EP DECAPOLAR CATHETER (401575/4200124); (407453/4354019)
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR