MAUDE Adverse Event Report: ST. JUDE MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605); Unspecified Vascular Problem (4441)

Event Type  Injury  

Event Description

Related manufacture ref: 3005334138-2023-00206.The following was published in the heart rhythm 20.5: 680-688.Elsevier b.V.(may 2023) in an article titled "very long term outcomes of atrial fibrillation ablation", winkle, roger.The purpose of this study was to evaluate very long term af ablation outcomes.Subjects were consecutive patients undergoing af ablation from october 10, 2003, to december 31, 2021.5200 patients were followed undergoing 7145 ablation procedures.We evaluated outcomes after single and multiple ablation procedures for paroxysmal (paf; 33.6%), persistent (peaf;56.4%), and long-standing (lsaf; 9.9%) af.We compared 3 ablation eras by initial ablation catheter: early (101 patients) using solid big tip (sbt) catheters (october 2003 to december 2005), intermediate (2143 patients) using open irrigated tip (oit) catheters (december 2005 to august 2016), and contemporary (2956 patients) using contact force (cf) catheters (march 2014 to december 2021) the following complications occurred: bleeding, pseudoaneurysm, unspecified tissue injury (groin complications), and an unspecified vascular problem (la-aortic root fistula).

Manufacturer Narrative

Concomitant device: tacticath¿ contact force ablation catheter, sensor enabled.

Manufacturer Narrative

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.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16941891
• MDR Text Key: 315329255
• Report Number: 3008452825-2023-00201
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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: 06/16/2023
• 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): Other