MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TRANSSEPTAL NEEDLE, BRK SERIES

Model Number AFD0030

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

Patient Problem Cardiac Perforation (2513)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in the final report.

Event Description

Related manufacturing ref: 3005334138-2019-00339, 3005334138-2019-00340, 3005334138-2019-00341, 2182269-2019-00087, 2182269-2019-00088, 2030404-2019-00050.At the completion of an rf ablation of the pulmonary veins, a pericardial effusion was noted during a routine ice evaluation of the heart.There was fluid seen in the pericardial sac.An echocardiogram was performed which confirmed the pericardial effusion and the patient¿s heart rate began to slow.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis. based on the information received, the cause of the reported incident could not be conclusively determined.Review of the device history record was not possible as the lot number is unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8752575
• MDR Text Key: 149771970
• Report Number: 3008452825-2019-00309
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AFD0030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/02/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS INTRODUCER; FLEXABILITY ABLATION CATHETER; INQUIRY STEERABLE EP CATHETER; REFLEXION SPIRAL EP CATHETER; SWARTZ INTRODUCER; SWARTZ INTRODUCER; AGILIS INTRODUCER; FLEXABILITY ABLATION CATHETER; INQUIRY STEERABLE EP CATHETER; REFLEXION SPIRAL EP CATHETER; SWARTZ INTRODUCER; SWARTZ INTRODUCER
• Patient Outcome(s): Required Intervention