MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A-FASE-DF

Device Problem Impedance Problem (2950)

Patient Problem Cardiac Perforation (2513)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

The reported power issue and pericardial effusion could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pericardial effusion cannot be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Additional manufacturer reference number: 3005334138-2017-00211, 2030404-2017-00045.During a left ventricular outflow ablation procedure, a pericardial effusion occurred.At the beginning of the procedure the geometry and activation map of the extra beat was performed but after approximately 15 minutes, the patient complained of a weight on his chest.A ecg didn't reveal any abnormality, so the procedure was continued.After determining the origin of the extra beat, which was in the mitral-aortic continuity, ablation was started at 30 watts with temperature control and 17 ml/minute irrigation via a transaortic approach.When the first lesion was placed the programmed watts were reached and the temperature was under 40 degrees celsius.When the second lesion was placed nearby the watts only reached 10 and the temperature rose to above 43 degrees celsius.The catheter connection cable was changed and the catheter tip was checked but the wattage remained low.The catheter was then exchanged and the first lesion was placed without issue but once again when the second lesion was being placed the wattage only went to 10.The catheter was replaced to a non-abbott device but there was some difficulty in placing the catheter back in the same region.Eventually the area was reached and ablation was continued however the extra beat would not disappear.Another physician was able to perform the ablation successfully.At the end of the ablation an echocardiogram was performed which revealed a pericardial effusion.A pericardiocentesis was started but eventually the patient was transferred to surgery.Perforations in the right atrium appendage, the aortic trunk and near the lesion in the left ventricle were found and repaired.The patient has remained in stable condition.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6998918
• MDR Text Key: 90952545
• Report Number: 3005334138-2017-00212
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: A-FASE-DF
• Device Lot Number: 5934199
• Other Device ID Number: 05415067020062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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: FLEXABILITY SE CATHETER; INQUIRY CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 74