MAUDE Adverse Event Report: ST. JUDE MEDICAL 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 Inflammation (1932); Pericardial Effusion (3271)

Event Date 10/15/2020

Event Type  Injury  

Event Description

Related manufacturing ref;ref:3005334138-2020-00526, 3008452825-2020-00579.During an epicardial ventricular tachycardia mapping procedure, a pericardial effusion occurred.While mapping the epicardium, the patient became hypotensive and an echocardiogram revealed a pericardial effusion for which a pericardiocentesis was performed to stabilize the patient.There were no performance issues detected with any abbott device.

Manufacturer Narrative

Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is (b)(4).

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 perforation remains unknown.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; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10733640
• MDR Text Key: 213010644
• Report Number: 3005334138-2020-00533
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: G408333
• Device Lot Number: 6935408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR HD GRID MAPPING CATHETER, SE; TACTICATH ABLATION CATHETER, SE; ADVISOR HD GRID MAPPING CATHETER, SE; TACTICATH ABLATION CATHETER, SE