MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number 407200

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

Patient Problem Cardiac Perforation (2513)

Event Date 04/04/2024

Event Type  Injury  

Event Description

During a mitraclip procedure, a pericardial effusion occurred which required a pericardiocentesis followed by open heart surgery to stabilize the patient.The procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and prolapsed posterior leaflet.A steerable guide catheter (sgc) was inserted without issues.However, while advancing the clip delivery system (cds), a perforation from the left atrium was observed by ultrasound.Pericardiocentesis was performed to treat the pericardial effusion.In the physician's opinion, the steerable guide catheter did not cause or contribute to the patient's pericardial effusion.The sgc and cds were removed together from the patient.The procedure was discontinued with no clips implanted, and the mr remained at a grade of 4.The patient was then transferred to the operating room (or) for open heart surgery.Suboptimal transseptal puncture due to "floppy" septum was noted.The patient remains in the hospital.There were no reported performance issues with the needle.The physician thinks due to the morphology of the septum (floppy) when he advanced the sgc, the tension was released and, the tip of the sgc caused the perforation on the left atrial wall.

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 incident could not be conclusively determined.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TROCAR
• 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: 19214328
• MDR Text Key: 341405132
• Report Number: 3008452825-2024-00246
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: (01)05414734205092(10)9182946(17)260731
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 05/16/2024

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
• Device Model Number: 407200
• Device Lot Number: 9182946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention