MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ INTRODUCER, UNKNOWN; TRANSSEPTAL CATHETER INTRODUCER

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

Patient Problems Arrhythmia (1721); Stroke/CVA (1770); Paralysis (1997); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: agilis¿ introducer, livewire¿ ep catheter, flexability ablation catheter.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 incidents remain unknown.

Event Description

Related manufacturing ref: 2182269-2019-00123, 2182269-2019-00124, 3005334138-2019-00467.The following was published in the heart rhythm.2018;15(1):65-74 titled: incidence and significance of adhesions encountered during epicardial mapping and ablation of ventricular tachycardia in patients with no history of prior cardiac surgery or pericarditis."a retrospective search of our ablation database containing patients who underwent epicardial ablation for vt was undertaken.Adhesions were diagnosed with routine contrast pericardiography after pericardial entry.Demographics and longterm outcomes were compared between patients with and without adhesions.The participants in this study comprised consecutive patients of age.18 years who underwent catheter ablation of ventricular tachycardia (vt) via percutaneous epicardial access.Exclusion criteria were documented prior cardiac surgery or those with a prior history of clinical pericarditis.The etiology of structural heart disease was established according to conventional diagnostic criteria, and patients were imaged preprocedurally with cardiac magnetic resonance imaging or transthoracic echocardiography or both.Where possible, antiarrhythmic drug therapy was withdrawn 5 half-lives prior to the procedure except in those patients on amiodarone.During the procedure, tamponade occurred in 6 patients, 1 patient had av block, 2 patients had transient phrenic nerve palsy, 1 patient had cerebrovascular accident (cva).Post procedure, 8 patients had heart failure or cardiogenic shock.

• Brand Name: SWARTZ¿ INTRODUCER, UNKNOWN
• Type of Device: TRANSSEPTAL CATHETER INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8942288
• MDR Text Key: 157045364
• Report Number: 3005334138-2019-00466
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052644
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• 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
• Date Manufacturer Received: 08/21/2019
• 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): Life Threatening; Required Intervention