MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-IRVINE) SAFIRE BLU DUO, MEDIGUIDE, 1304-CP2S-8-25-MC-BD-ME

Model Number A700238

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Thrombosis (2100); Burn, Thermal (2530)

Event Date 01/31/2014

Event Type  Injury  

Event Description

During an atrial fibrillation ablation procedure using a safire blu duo ablation catheter, a hematoma on the posterior wall of the left atrium and thermal damage to the esophagus occurred.The pulmonary veins were isolated using a safire blu duo ablation catheter guided by an agilis nxt introducer.Approx 45 mins after the last lesion, the anesthesia team noted bleeding from the pt's mouth.A gi physician assessed the pt and determined that there was damage to the right side of the posterior wall of the left atrium (la) due to ablation.As a result of the damage to the la, the esophagus was also damaged.The pt was taken to surgery, which revealed a hematoma on the posterior wall of the left atrium and thermal damage to the esophagus.No repair was required for either structure, except removal of clots from the hematoma.The pt had a stroke two days later and is currently intubated in the icu.The cause of the stroke remains unclear.

• Brand Name: SAFIRE BLU DUO, MEDIGUIDE, 1304-CP2S-8-25-MC-BD-ME
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-IRVINE); irvine CA
• Manufacturer Contact: denise johnson, rn ; 177 east county road b; st. paul, MN 55117 ; 6517564470
• MDR Report Key: 3676758
• MDR Text Key: 17843027
• Report Number: 2030404-2014-00017
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110016
• 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: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A700238
• Device Lot Number: 436006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2014
• 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: VIEWFLEX ICE CATHETER (MODEL/LOT UNK); (D402058/LOT UNK); MEDIGUIDE ENABLE LIVEWIRE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR