MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS¿ EPI STEERABLE INTRODUCER DUAL-REACH¿ 40 CM SHEATH, SMALL CURL, 8.5F; INTRODUCER, CATHETER

Model Number G408333

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

Patient Problems Laceration(s) (1946); Cardiac Perforation (2513)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in a subsequent submission.

Event Description

During a ventricular tachycardia ablation procedure a pericardial effusion occurred.Following transseptal puncture a pericardial effusion was noted.When the effusion did not resolve on its own the patient was transferred to surgery to stop the bleeding and stabilize the patient.Surgical repair confirmed the patient had two lacerations in the right ventricle.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.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 laceration and pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: AGILIS¿ EPI STEERABLE INTRODUCER DUAL-REACH¿ 40 CM SHEATH, SMALL CURL, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8619350
• MDR Text Key: 145360564
• Report Number: 2182269-2019-00061
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: G408333
• Device Lot Number: 5566918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention