MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS INTRODUCER, UNKNOWN; INTRODUCER, CATHETER

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

Patient Problems Death (1802); Cardiac Perforation (2513)

Event Date 06/13/2019

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event was requested but not received.

Event Description

Related manufacturer reference: 3005334138-2019-00343, 2182269-2019-00093, 3005334138-2019-00368, 2030404-2019-00054, 3005334138-2019-00369, 3005334138-2019-00370, 2182269-2019-00095.During an ventricular tachycardia ablation procedure, a cardiac tamponade occurred.During left bundle right superior axis with v2 transition, the patient became hemodynamially unstable.Pacemaking was terminated and ice confirmed a circumferential pericardial effusion.A pericardiocentesis was performed and the drain was left in place.Perclose was administered.The patient was stable and discharged.There were no performance issues with any abbott device.

Event Description

Further information received confirmed the patient expired.The patient was admitted for sepsis, acute leg pain and atp.The principle diagnosis was cardiogenic shock, septic shock and empyema.The patient became hypotensive and hypoxic, and later expired.The cause of death is unknown, however it is not attributed to the ablation procedure or study device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported cardiac tamponade could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Additional information received indicated a pleural effusion occurred with the patient on (b)(6) 2020, however no further details regarding the effusion is available and it is unknown if it is related to the originally reported ablation procedure.

• Brand Name: AGILIS INTRODUCER, UNKNOWN
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8780290
• MDR Text Key: 150691799
• Report Number: 2182269-2019-00094
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/27/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 07/15/2019; 12/11/2019; 07/29/2020
• Supplement Dates FDA Received: 07/19/2019; 12/17/2019; 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR¿ HD GRID MAPPING CATHETER, SE; AGILIS¿ INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; LIVEWIRE¿ EP CATHETER DUO-DECAPOLAR; SWARTZ¿ BRAIDED INTRODUCER, LAMP; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; VIEWFLEX¿ XTRA ICE CATHETER; ADVISOR¿ HD GRID MAPPING CATHETER, SE; AGILIS¿ INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; LIVEWIRE¿ EP CATHETER DUO-DECAPOLAR; SWARTZ¿ BRAIDED INTRODUCER, LAMP; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; VIEWFLEX¿ XTRA ICE CATHETER
• Patient Outcome(s): Death; Other
• Patient Age: 67 YR
• Patient Weight: 87