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

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

Patient Problem Aortic Dissection (2491)

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): flexibility ablation catheter the results of the investigation are inconclusive since the device was not returned for analysis.Additionally, a device history record (dhr) was unable to be reviewed since a lot number was not provided.Based on the information received, the cause of the reported cardiac tamponade and aortic dissection could not be conclusively determined.Per the ifu, cardiac perforation and intimal dissection are a known risk during the use of this device.

Event Description

Related manufacturing ref: 3005334138-2019-00405.The following was published in the journal, "cardiac arrhythmias" titled, "electrocardiographic predictors of outcome after radiofrequency catheter ablation of frequent non-ischemic premature ventricular complexes": among the 63 patients undergoing the ablation procedure, three patients (4.7%) had major complications, two had cardiac tamponade that required urgent pericardiocentesis, and one patient had aortic dissection managed conservatively.No stroke, av block or death were reported.The tamponades were due to ablating with the flexibility in the rvot.

• Brand Name: VIEWFLEX¿ 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8850012
• MDR Text Key: 152910645
• Report Number: 2030404-2019-00061
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K133853
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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: 07/12/2019
• 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
• Patient Outcome(s): Required Intervention