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 Bradycardia (1751); Hematoma (1884); Cardiac Perforation (2513)

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 not reviewed as the batch number was not available.Based on the information received, the cause of the reported cardiac tamponade, hematomas, and bradycardia could not be conclusively determined.

Event Description

Related manufacturer reference: 3005334138-2019-00412, 2030404-2019-00065, 2030404-2019-00066.The following was published in jafib: journal of atrial fibrillation in an article titled "atrial fibrillation in heart failure patients with preserved or reduced ejection fraction - prognostic significance of rhythm control strategy with catheter ablation" by vecchio n, ripa l, orosco a, et al., february - march 2019.Vol 11 issue 5."atrial fibrillation (af) and heart failure (hf) often coexist with an increase in morbidity and mortality.Af catheter ablation (ca) has proved to be a safe and efficient option for hf patients, but long-term evolution and prognosis remain uncertain.The aim is to assess the efficacy and safety of ca in hf patients with af, and analyze hf long-term evolution.Consecutive patients with af and congestive hf or left ventricular ejection fraction (ef) less than 45%, who underwent ca of af between 2011 and 2016, were prospectively analyzed.It was concluded that catheter ablation of atrial fibrillation in heart failure presents an adequate success rate, improving symptoms and reducing rehospitalizations due to heart failure.However, during the study two cardiac tamponades requiring pericardiocentesis, three groin hematomas and 1 case of extreme bradycardia were observed.".

• 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: 8841749
• MDR Text Key: 152661795
• Report Number: 3005334138-2019-00413
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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: 07/12/2019
• 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
• Treatment: INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER; SWARTZ¿ INTRODUCER; THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER
• Patient Outcome(s): Required Intervention