MAUDE Adverse Event Report: ST JUDE MEDICAL, INC. (AF-IRVINE) INQUIRY OPTIMA STEERABLE, 1110-7-7-SM-OPT25

Model Number 81687

Device Problem Difficult To Position (1467)

Patient Problem Pericardial Effusion (3271)

Event Date 01/23/2014

Event Type  Injury  

Event Description

During a pulmonary vein isolation procedure using an inquiry optima catheter, a pericardial effusion occurred.Ultrasound revealed the pt had atypical vascular anatomy, so only one venous access was obtained in the left and the right femoral veins.A viewflex xtra ice catheter was advanced to the right atrium with difficulty due to the pt's anatomy.Transseptal puncture was performed with an agilis nxt introducer and a brk trasseptal needle.An inquiry optima ep catheter was advanced into the left atrium.Geometry was collected and edited.The inquiry optima ep catheter was then exchanged for a safire blu duo ablation catheter.Radiofrequency lesions were performed around the right superior and the left inferior pulmonary veins for approximately 10 minutes.At this time, a pericardial effusion was noted vie the ice catheter.The pt remained stable so ablation was continued.A pericardiocentesis was then performed, the heparin infusion was discontinued, and protamine and fresh frozen plasma were administered.The effusion slowed and stopped after approximately two hours.A pericardial drain was left in place overnight and removed the following morning.The pt had no further issues.There were no performance issues with any sjm device.

• Brand Name: INQUIRY OPTIMA STEERABLE, 1110-7-7-SM-OPT25
• 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: 3672011
• MDR Text Key: 4340936
• Report Number: 2030404-2014-00013
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042775
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 81687
• Device Lot Number: 4233612
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: No
• 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: SAFIRE BLU DUO ABLATION CATHETER (A088107/4243851); LIVEWIRE EP DECAPOLAR CATHETER(401575/4279938); BRK TRANSSEPTAL NEEDLE (G407212/4293866); AGILIS NXT INTRODUCER (408309/LOT UNK); VIEWFLEX XTRA ICE CATHETER (D087031/4192204)
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 129