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

Model Number 408309

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

Patient Problem Death (1802)

Event Date 11/29/2018

Event Type  Death  

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 patient expiration could not be conclusively determined.

Event Description

Related manufacturing reference: 9680001-2018-00186, 3005334138-2018-00512, 3008452825-2018-00436, 2182269-2018-00146, 3008452825-2018-00439.Two days following a pulmonary vein isolation procedure the patient expired.No device performance issues were noted throughout the procedure.Post ablation the patient went into atrial fibrillation and was cardioverted.A transesophageal echo was performed revealing no tamponade or clots in the left atrial appendage.The patient was discharged from the hospital on (b)(6) 2018 and expired (b)(6) 2018.A coroner's ct scan confirmed there was no tamponade, clots, or esophageal injury.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, SMALL CURL, 8.5F
• 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: 8180939
• MDR Text Key: 130897098
• Report Number: 3008452825-2018-00435
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206099
• UDI-Public: 05414734206099
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061363
• 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: 12/19/2018

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 Expiration Date: 08/31/2021
• Device Model Number: 408309
• Device Catalogue Number: 408309
• Device Lot Number: 6638052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2018
• 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: BRK-1¿ XS TRANSSEPTAL NEEDLE; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; REFLEXION¿ SPIRAL CATHETER; TACTICATH¿ QUARTZ ABLATION CATHETER
• Patient Outcome(s): Death