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

Model Number D087031

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

Patient Problem Complete Heart Block (2627)

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported heart block could not be conclusively determined.

Event Description

Related manufacturer reference: 2182269-2017-00056, 2182269-2017-00057.During a cryo ablation procedure, the patient developed complete heart block.The livewire and supreme catheters were in the heart, and the viewflex ice catheter was being placed in the heart in preparation for the transseptal left side access when the heart block occurred.It is unknown which catheter made contact with the his region in the heart, causing the heart block.The patient had to be emergently paced, however the procedure was completed and the patient was followed and paced overnight.Electrical conduction was regained and the patient was stabilized.

• 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: 6508936
• MDR Text Key: 73329545
• Report Number: 2030404-2017-00013
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D087031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• 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: BARD RECORDING SYSTEM; ENSITE VELOCITY AMPLIFIER; LIVEWIRE STEERABLE CATHETER; MEDTRONIC CRYO GENERATOR; MICROPACE STIMULATOR; SUPREME ELECTROPHYSIOLOGY CATHETER; VIEWMATE SYSTEM
• Patient Outcome(s): Required Intervention