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

Model Number 401575

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 03/13/2018

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 may have been procedure related.

Event Description

During a crt-d implant, a coronary sinus dissection occurred.After placing the rv lead, coronary sinus cannulation was difficult to achieve.After using several tools to cannulate the coronary sinus (cs), a dissection occurred.The dissection was visualized on the fluoroscopy after dye injection into the cs.There was no intervention required and the patient is in stable condition.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Type of Device: CATHETER, 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7361643
• MDR Text Key: 103170497
• Report Number: 2182269-2018-00053
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K913940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 401575
• Device Catalogue Number: 401575
• Device Lot Number: 6159002
• Other Device ID Number: 05414734202183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR