MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY ABLATION CATHETER-UNKNOWN; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

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

Patient Problems Cardiac Perforation (2513); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): swartz introducer, swartz introducer, brk transseptal needle, tacticath quartz ablation catheter, inquiry optima diagnostic loop catheter.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 incidents 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: 3005334138-2020-00144, 3005334138-2020-00145, 3008452825-2020-00176, 9680001-2020-00016, 2030404-2020-00023.In an article published in wiley, journal of arrhythmia, titled, "the impact of the presence of left atrial low voltage areas on outcomes from pulmonary vein isolation" by ahmed-jushuf, fiyyaz et al.: four (2.5%) patients experienced major procedural complications comprising of a mitral valve injury because of the multipolar mapping catheter entrapment (n = 1), pericardial effusion requiring percutaneous drainage (n = 2), and a right leg pseudoaneurysm (n = 1).

• Brand Name: FLEXABILITY ABLATION CATHETER-UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9902738
• MDR Text Key: 186600112
• Report Number: 3005334138-2020-00146
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• 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: 03/17/2020
• 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