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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES), CATHETER, STEERABLE

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ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES), CATHETER, STEERABLE Back to Search Results
Model Number 401932
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 07/22/2019
Event Type  Injury  
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 dissection could not be conclusively determined.
 
Event Description
Related manufacturing reference: 3008452825-2019-00404, 3008452825-2019-00405, 3008452825-2019-00407. During an atrial fibrillation and atrial flutter ablation procedure a dissection occurred. During the procedure, as the physician was guiding the devices through a narrow left iliac vein, the patient became hypotensive. A hemoglobin test was run and it was determined the patient needed a blood transfusion. Contrast was injected to determine the location of the bleeding and a dissection was found. Vascular intervention was not required as the dissection closed on its own. The procedure was completed and the patient was stable. There were no performance issues with any abbott device.
 
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Brand NameLIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8883686
MDR Text Key153977207
Report Number2182269-2019-00113
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K913940
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2022
Device Model Number401932
Device Catalogue Number401932
Device Lot Number6874133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/12/2019 Patient Sequence Number: 1
Treatment
INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER X2; VIEWFLEX¿ XTRA ICE CATHETER
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