MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE

Model Number	401575
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a cardiac resynchronization therapy implant procedure, a pericardial effusion occurred.The cps direct universal slit table outer catheter was placed into the coronary sinus with guidance of the livewire catheter.Then a balloon catheter was inserted and inflated but the venogram wasn't clear so the balloon was deflated and removed.The patient became hypotensive and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed and adrenaline was administered to stabilize the patient.
Additional Manufacturer Narrative
The reported event of a pericardial effusion could not be confirmed.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 pericardial effusion could not be conclusively determined.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8122944
• Report Number: 2182269-2018-00141
• Device Sequence Number: 13501072
• Product Code: DRA
• UDI-Device Identifier: 05414734202183
• UDI-Public: 05414734202183
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K913940
• 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): 12/05/2018

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: 06/30/2021
• Device Model Number: 401575
• Device Catalogue Number: 401575
• Device Lot Number: 6553960
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 12/02/2018
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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: Required Intervention
• Patient Age: 82 YR