MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ DIAGNOSTIC CATHETER MEDIGUIDE ENABLED¿, MEDIUM SWEEP ELECTRODE SPACING; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D402058
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/29/2019
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 dissection may have been procedure related.
Event or Problem Description
During a coronary sinus cannulation, a dissection occurred.No intervention was required to treat the dissection and the patient remained stable.Another procedure will be scheduled once the dissection heals.

• Brand Name: LIVEWIRE¿ DIAGNOSTIC CATHETER MEDIGUIDE ENABLED¿, MEDIUM SWEEP ELECTRODE SPACING
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9340332
• Report Number: 2182269-2019-00240
• Device Sequence Number: 2225194
• Product Code: DRF
• UDI-Device Identifier: 05414734216890
• UDI-Public: 05414734216890
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101955
• 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): 11/19/2019

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: No Information
• Device Expiration Date: 11/30/2020
• Device Model Number: D402058
• Device Lot Number: 6979061
• 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: 10/29/2019
• Initial Report FDA Received Date: 11/19/2019
• 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