MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. COOL PATH¿ IRRIGATED ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

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

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: flexability¿ ablation catheter, swartz¿ introducer, agilis¿ introducer.The results of the investigation are inconclusive since the device was not returned for analysis.Additionally, no lot number was provided so a review of the device history record (dhr) was not possible.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturing ref: 3005334138-2019-00297, 3005334138-2019-00298, 182269-2019-00078.The following was published in the journal of arrhythmia in an article titled, "pulmonary vein isolation plus left atrial posterior wall isolation and additional nonpulmonary vein trigger ablation using high-dose isoproterenol for long-standing persistent atrial fibrillation" by tomomasa takamiya, md, junichi nitta, md, akira sato, md, et al., on feb.18, 2019."the median procedure time was 183 (q1-q3; 155-220) minutes.Complications occurred in 7 of 226 (3%) procedures; 4 (2%) patients had pericardial effusion that required percutaneous drainage, 2 (1%) had gastroparesis, and 1 (0.4%) patient had an esophageal ulcer.All patients were conservatively treated without long-term sequelae.".

• Brand Name: COOL PATH¿ IRRIGATED ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS 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: 8678538
• MDR Text Key: 147323017
• Report Number: 2030404-2019-00041
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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: 05/14/2019
• 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