MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL; CATHETER, STEERABLE

Model Number	401908
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemothorax (1896); Cardiac Perforation (2513)
Date of Event	05/08/2020
Type of Reportable Event	Serious Injury
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 was requested but not received.
Event or Problem Description
Related manufacturer reference: 3008452825-2020-00255, 3008452825-2020-00256, 3008452825-2020-00257, 2182269-2020-00051.During ventricular tachycardia mapping in the left ventricle, a pericardial effusion occurred.After approximately an hour of mapping, using transseptal approach, the patient became hypotensive.An ultrasound confirmed a pericardial effusion for which a pericardiocentesis was administered.An additional ultrasound confirmed a left hemothorax, which required a drain.The cause and location of the pericardial effusion remains unknown, however it was noted the transseptal puncture was difficult.The patient was stable with minimal use of catecholamines and transferred to the icu.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Additional information: d10, g4, g7, h2, h3, h6, h10.One livewire¿ electrophysiology catheter was received for investigation.Electrode 10 read as an open circuit.Electrode ring 10 was dissected to reveal that conductor wire 10 was fractured proximal to the weld joint, consistent with the open circuit detected.Electrodes 1-9 and 11-20 met specifications of acceptable resistance values with no open or short circuits detected.A bend in the shaft was also noted.The catheter shaft was able to deflect when actuating the steering mechanism; however, the catheter no longer met specifications for curve shape due to a bend in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wire and bend in the shaft is consistent with damage during use.The cause of the pericardial effusion remains unknown as it could not be confirmed.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 10098867
• Report Number: 2182269-2020-00050
• Device Sequence Number: 19787561
• Product Code: DRA
• UDI-Device Identifier: 05414734202558
• UDI-Public: 05414734202558
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K022380
• 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): 08/18/2020

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: 07/31/2022
• Device Model Number: 401908
• Device Catalogue Number: 401908
• Device Lot Number: 7125108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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: AGILIS¿ NXT STEERABLE INTRODUCER; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; SUPREME¿ ELECTROPHYSIOLOGY CATHETER; TRANSSEPTAL NEEDLE, BRK SERIES
• Outcome Attributed to Adverse Event: Other