MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH

Model Number G407211

Device Problem Difficult to Insert (1316)

Patient Problem Cardiac Perforation (2513)

Event Date 08/08/2022

Event Type  Injury  

Event Description

During a persistent atrial fibrillation ablation procedure, an effusion occurred.Two transseptal punctures were performed to advance the catheters into the left atrium (la) at the same time.The first transseptal puncture went fine, however, the second seemed more difficult to the physician.Just after the second puncture, an echocardiogram was done which confirmed there was no effusion.The patients vitals were normal and stable.After mapping, ablation of the roof line and anterior line were completed.The patient became hypotensive and a recheck echo revealed an effusion all around the heart.A pericardiocentesis was performed which stabilize the patient and the procedure was stopped.The physician assumed the effusion occurred after the second transeptal puncture with the needle.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• 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: 15232089
• MDR Text Key: 297948426
• Report Number: 3008452825-2022-00551
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: 05414734205153
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122587
• 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
• Report Date: 09/21/2022

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
• Device Model Number: G407211
• Device Catalogue Number: G407211
• Device Lot Number: 8526504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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