MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; INTRODUCER, CATHETER

Model Number	406902
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Death (1802); Respiratory Failure (2484)
Date of Event	01/08/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
Event or Problem Description
Related manufacturer reference: 3008452825-2020-00015, 3005334138-2020-00019, 3008452825-2020-00016, 3008452825-2020-00017, 3008452825-2020-00018, 3008452825-2020-00019, 3005334138-2020-00021.During the mapping of a ventricular tachycardia ablation procedure, following mapping of the right and left ventricle, the patient experienced respiratory failure and pulseless electrical activity.An immediate cardiac massage was performed, without the restoration of natural heart contraction.There was no pericardial effusion visible with the intracardiac echo and the procedure was interrupted before the ablation.The patient expired.The cause of the respiratory failure and subsequent death is unknown.There were no performance issues with any abbott device.
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 respiratory failure and subsequent death could not be conclusively determined.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9590539
• Report Number: 3005334138-2020-00020
• Device Sequence Number: 328006
• Product Code: DYB
• UDI-Device Identifier: 05414734203456
• UDI-Public: 05414734203456
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 02/17/2020

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: 01/31/2022
• Device Model Number: 406902
• Device Catalogue Number: 406902
• Device Lot Number: 6868904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ HD GRID MAPPING CATHETER, SE; BRK-1¿ XS TRANSSEPTAL NEEDLE; FLEXABILITY¿ ABLATION CATHETER, SE; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER (X2); SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; VIEWFLEX¿ XTRA ICE CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Weight: 48