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 Thrombus (2101); Cardiac Perforation (2513)

Event Date 11/04/2019

Event Type  Injury  

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 incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

The following event was found during a search of the maude database performed on 29 april 2020, report number: 2029046-2019-03939: it was reported that a female patient underwent a persistent atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention, thrombosis and tachycardia.During the procedure, during the transseptal phase, the attending and the fellow had completed first transseptal puncture, with the ablation catheter across and were working on getting the second transseptal puncture.The physician and fellow were working strictly with an intracardiac echocardiogram (ice) to achieve the transseptal puncture.While working through multiple ice views with the second transseptal needle, the physician postulated that he saw a view in which the needle had jumped into the right atrial appendage and that is where the potential perforation happened.The attending immediately noticed a severe drop in heart rate (down to 28 bpm) with accompanying hypotension.The fellow used the ice to confirm cardiac tamponade due to the pericardial effusion from accidental transseptal needle puncture.A pericardiocentesis was performed and 1500cc of fluid/blood was removed with about 1l reinfused back into the patient.The patient stabilized for about 30 minutes until the attending noticed what looked like a large clot swirling around in the right atrium.Shortly after, the patient's heart rate went tachycardic and blood pressure dropped.The decision was made to get the patient to cardiac surgery for puncture repair following this further complication.The puncture was discovered in the right ventricle, where a few stitches were placed to close the hole.The patient was hospitalized for about a week post-surgical intervention before being discharged.Their condition has improved.Patient has a history of stroke prior to procedure.A transesophageal echocardiogram was performed before the procedure and there was no evidence of clots or prior effusion.Transseptal puncture was performed with a 71 cm brk needle manufactured by abbott.No ablation had been performed prior to the cardiac tamponade.The cardiac tamponade event was related to use of the transseptal needle.The puncture was discovered in the right ventricle where no product was used specifically.

• 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: 10060671
• MDR Text Key: 191082753
• Report Number: 3008452825-2020-00237
• 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: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• 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: 04/29/2020
• 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