MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VIEWFLEX¿ XTRA ICE CATHETER

Model Number D087031

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

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 incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

During a 3d mapping procedure of the left ventricle a cardiac tamponade occurred.A retrograde approach was being used and after approximately one hour into the procedure the patient became hypotensive.An echocardiogram was performed and small liquid accumulation was found around the ventricle but it was not possible to establish if it was from prior to the procedure or not.The procedure was stopped and the patient¿s condition monitored.When leaving the operating room the patient¿s blood pressure began to fluctuate again.A transesophageal echocardiogram was used and a cardiac tamponade was noted.A pericardiocentesis was performed and a drain was placed to stabilize the patient.It was noted during the procedure that noise was experienced on the intracardiac echocardiography catheter.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Type of Device: ICE CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7604779
• MDR Text Key: 111150571
• Report Number: 2030404-2018-00042
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 05415067002082
• UDI-Public: 05415067002082
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121381
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: D087031
• Device Lot Number: 6273025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2018
• 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
• Patient Outcome(s): Other