MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES, SL3 8F; INTRODUCER, CATHETER

Model Number	406842
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Type of Reportable Event	Serious Injury
Additional 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 incident could not be conclusively determined.Concomitant devices with unknown therapy date: tacticath¿ contact force ablation catheter, sensor enabled¿ bid curve d-f, fast-cath¿ transseptal guiding introducer swartz¿ sl transseptal series, sl1¿ 8.5f, fast-cath¿ transseptal guiding introducer swartz¿ sl transseptal series, sl1¿ 8.5f.
Event or Problem Description
Related manufacturer report number: 3008452825-2020-00602, 3005334138-2020-00546, 3005334138-2020-00547.Following an af ablation procedure, the patient experienced a stroke.There were no performance issues with any abbott devices.A transesophageal echo was performed to exclude a left atrial appendage (laa) thrombus, there was question of a thrombus in the laa but it was decided to be unlikely.A target act of 300 or above is maintained for all la ablations per the representative.The physician did not allege any abbott product was the cause for the cva.

• Brand Name: FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES, SL3 8F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10787557
• Report Number: 3005334138-2020-00545
• Device Sequence Number: 3798560
• Product Code: DYB
• UDI-Device Identifier: 05414734203364
• UDI-Public: 05414734203364
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 406842
• Device Catalogue Number: 406842
• Device Lot Number: 7523495
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other