MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(AF-IRVINE) VIEWFLEXICE CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, bleeding may occur as a result of the delivery of electrical energy during internal defibrillation or at the catheter introducer site.

Event Description

Related manufacturer ref: 2182269-2021-00047, 3008452825-2021-00269, 2182269-2021-00048.Following a cryo balloon atrial fibrillation procedure, the patient became hypotensive after leaving the room and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.The physician did not allege any particular device as causing the pericardial effusion.No perforation was noted during the procedure.There were no patient symptoms during the procedure and the procedure had been deemed successful per the physician.There were no performance issues with any abbott devices.

• Brand Name: VIEWFLEXICE CATHETER
• Type of Device: ICE CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(AF-IRVINE); 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11820266
• MDR Text Key: 250469730
• Report Number: 2030404-2021-00030
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2021
• 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: AGILIS INTRODUCER; LIVEWIRE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER; SUPREME ELECTROPHYSIOLOGY CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 91