MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, MEDIUM CURL, 8.5 F; INTRODUCER, CATHETER

Model Number 408310

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

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Manufacturing related ref: , 3005334138-2019-00371, 3008452825-2019-00328, 3005334138-2019-00372.During the pulmonary vein isolation (pvi) ablation procedure, the patient experienced a pericardial effusion.An ice catheter was used to view the ventricles and pericardium throughout the procedure and the user noted a small effusion developing during the left vein wide atrial circumferential ablation.The effusion was in the left atrium and the patient experienced reduced blood pressure and cardiac tamponade.The procedure was stopped and protamine was administered and a pericardiocentesis was performed with the placement of a pericardial drain.There were no performance issues with an abbott device.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, MEDIUM CURL, 8.5 F
• Type of Device: INTRODUCER, CATHETER
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8781879
• MDR Text Key: 150740830
• Report Number: 3008452825-2019-00329
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206105
• UDI-Public: 05414734206105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 408310
• Device Catalogue Number: 408310
• Device Lot Number: 6937779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2019
• 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: ADVISOR¿ FL, SE CATHETER¿; SWARTZ¿ BRAIDED INTRODUCER; TACTICATH¿ SE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 79