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

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

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

The following was published in an article titled "transseptal puncture in children under 20 kg", the author(s), 2022.Published by cambridge university press, volume 32, supplement 2, pages s1¿s279.Between january 2006 and july 2021 33 berlin heart excor© devices were implanted in paediatric patients.We analysed preoperative and intraoperative characteristics, as well as complications after the implant (haemorrhagic, infectious, thromboembolic and neurological).Outcomes of the patients were also evaluated (transplant vs.Death).Sa total of 21 patients were included in this study.Eight of them were girls.The mean age of the patients was 3.4 years (0 days-8.4 years).9/21 of these patients had a bodyweight of less than 10 kg, and the remaining 12/21 patients were between 10-20 kg (mean 11 kg (2.7-20kg)).The median procedure and fluoroscopy times were 140 min and 3 min, respectively.Tp was performed in 7 patients during an electrophysiological study due to svt.Tp was performed in 7 patients with hypoplastic left heart syndrome to create an interatrial shunt.In 7 patients, tp was performed to cre-ate a right-left shunt due to pulmonary hypertension.Tp was not successful in 4 patients.The mean weight of the patients who failed tp was 4.5 kg.The only major complication was pericardial tamponade developed in a patient diagnosed with complex congenital heart disease(chd).Conclusion: in conclusion, transseptal puncture can be performed safely in suitable patients.It may be riskier in complex chd patients with abnormal cardiac anatomy than patients with normal cardiac anatomy performed for the electrophysiological study.Pericardial effusion/cardiac tamponade occurred during the study.

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 pericardial effusion/cardiac tamponade remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

Manufacturer Narrative

Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is (b)(4).

Event Description

This report was submitted initially on the tacticath ablation catheter.In reviewing the file, it was determined that it should be on the brk transseptal needle.

Manufacturer Narrative

Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is 3008452825.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica MN 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15708110
• MDR Text Key: 302772515
• Report Number: 3005334138-2022-00596
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 01/12/2023; 03/30/2023; 03/30/2023
• Supplement Dates FDA Received: 01/16/2023; 03/30/2023; 04/09/2024
• 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