MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8F; INTRODUCER, CATHETER

Model Number 407449

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

Patient Problem Death (1802)

Event Date 02/07/2020

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 death could not be conclusively determined.

Event Description

Related manufacturer reference: 3008452825-2020-00126, 3005334138-2020-00078, 2182269-2020-00024, 3008452825-2020-00127, 3008452825-2020-00128.During a left atrial flutter ablation, a possible stroke and subsequent death occurred.It was indicated the cause of death may have been a stroke.The ablation itself was not the alleged cause of death, however, the cause is unknown.The death occurred 72 hours following the ablation procedure.There were no performance issues with any abbott device.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9820020
• MDR Text Key: 183000451
• Report Number: 3005334138-2020-00079
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205733
• UDI-Public: 05414734205733
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052644
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 407449
• Device Catalogue Number: 407449
• Device Lot Number: 7239329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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¿ HD GRID MAPPING CATHETER, SE; AGILIS¿ NXT STEERABLE INTRODUCER; BRK¿ XS TRANSSEPTAL NEEDLE; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
• Patient Outcome(s): Death
• Patient Age: 75 YR