MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

Model Number G407209

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

Patient Problems Air Embolism (1697); Cardiac Perforation (2513)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturing reference:3005334138-2018-00045, 3005334138-2018-00046, 2182269-2018-00030, 2182269-2018-00031.During paroxysmal atrial fibrillation ablation procedure, st elevation was noted and a pericardial effusion occurred.While in the waiting phase of the procedure, it was noticed that the patient had st elevation.After flushing fluids through all the lines, approximately 10 minutes later the st segment returned back to normal and a precautionary angiogram was performed with no abnormalities observed.After this, the pulmonary veins were checked for isolation which was successful and the case was concluded.During the post assessment, an echocardiogram was performed, which revealed pericardial separation pointing to a pericardial effusion at the left atrial side.A pericardial drain was placed and the patient is in stable condition and being observed.There were no performance issues with any abbott devices.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7278196
• MDR Text Key: 100313364
• Report Number: 3008452825-2018-00045
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072278
• 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: 02/16/2018

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: G407209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/16/2018
• 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: AGILIS INTRODUCER; J&J LASSO CATHETER; LIVEWIRE EP CATHETER; SWARTZ BRAIDED INTRODUCER; TACTICATH ABLATION CATHETER, SE
• Patient Outcome(s): Required Intervention