MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA AGILIS¿ INTRODUCER, UNKNOWN; TRANSSEPTAL NEEDLE

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

Patient Problem Air Embolism (1697)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported air embolism could not be conclusively determined.Per the ifu, air embolism is a known risk during the use of this device.

Event Description

During an atrial fibrillation ablation procedure, an air embolism occurred.Several minutes after transseptal puncture was performed, the patient developed st elevation and third degree av.Ventricular pacing and cpr was performed for a short time and symptoms then resolved without sequelae.There were no performance issues with sjm devices and this event was considered to be procedure related.

• Brand Name: AGILIS¿ INTRODUCER, UNKNOWN
• 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: 5748997
• MDR Text Key: 48152107
• Report Number: 3008452825-2016-00081
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• 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
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADVISOR FL CIRCULAR MAPPING CATHETER
• Patient Outcome(s): Other
• Patient Age: 59 YR