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

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

Patient Problems ST Segment Elevation (2059); Transient Ischemic Attack (2109); 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 pericardial effusion, st elevation, and transient ischemic attack could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

The following was published in pacing and clinical electrophysiology: pace in an article titled "over-the-needle trans-septal access using the cryoballoon delivery sheath and dilator in atrial fibrillation ablation" by e ströker et al., 2019; 42: 868-873.Doi: 10.1111/pace.13709.In the setting of second-generation cryoballoon (cb2) ablation, left atrial (la) access is generally achieved using a standard sheath (ss) that is exchanged for the 15fr cryoballoon delivery sheath (cbs) and dilator over a long wire (cbs over-the-wire technique, cbs-w).The objective was to evaluate the direct use of the cbs to gain la access, by advancing the latter over the trans-septal needle (cbs over-the-needle technique, cbs-n), under transesophageal echocardiographic (tee) guidance.This study showed that the cbs-n technique is feasible and safe under echocardiographic guidance.Without sheath exchange, it simplifies the cb2 procedure, is less costly, time sparing, and might reduce the risk of air embolism.Between 2015-2017, a total of 505 consecutive patients who underwent the cbs-n approach were evaluated for feasibility.La access with the cbs-n approach could be achieved in all patients, without modification of the technique or use of additional equipment.Circumferential pericardial effusion was seen in 3 patients on the tte post-procedure, categorized as mild (<10 mm) in two patients and moderate (10-20 mm) in one patient, transient st elevation occurred in 5 patients, and transient ischemic attack occurred in 3 patients with no anomalies observed on the ct scan not requiring intervention.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9948119
• MDR Text Key: 187532475
• Report Number: 3008452825-2020-00193
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• 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: 03/24/2020
• 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