MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER; ELECTRODE RECORDING CATHETER

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Cardiac Perforation (2513); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: flexability catheter, swartz introducer, event date unknown.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturer reference number: 3005334138-2019-00459, 3005334138-2019-00460.The following was published in heart rhythm society in an article titled ¿hybrid surgical vs percutaneous access epicardial ventricular tachycardia ablation by li a, hayase j, do d, et al., 2018;15:512¿519.¿we performed a retrospective study of consecutive surgical epicardial ventricular tachycardia (vt) ablation cases from a single center.Surgical cases were propensity-matched to percutaneous epicardial ablation controls and short-term and long-term outcomes were compared.The study population comprised 38 consecutive patients who underwent mapping and ablation using a hybrid surgical technique at the university of california los angeles cardiac arrhythmia center between 2004 and 2016.Short-term procedural complications occurred, including generalized bleeding with no focal source in 1 patient, which prevented anticoagulation for endocardial lv mapping.Damage to the ventricle requiring intraoperative repair occurred in 2 patients during adhesiolysis, requiring a simple oversew.Damage to an epigastric artery occurred in 1 patient, requiring extension of the initial access for exploration and clipping.There was also 1 instance of wound infection and 2 vascular access complications.(https://doi.Org/10.1016/j.Hrthm.2017.11.009).

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• 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 Key: 8925943
• MDR Text Key: 155962775
• Report Number: 2182269-2019-00119
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention