MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number G407212

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/12/2023

Event Type  Injury  

Event Description

Related manufacturing ref: 3008452825-2023-00030.During a right and left atrial procedure in a patient with a congenital heart defect and junctional ectopic tachycardia, cryo ablation was performed in both the left and right atrium with a medtronic freezr.After the procedure was finished, an unknown particle was noted in the left atrium in the ultrasound imaging.The particle could be a thrombus but could not be confirmed during procedure.It was also thought to be a particle from an inserted product.In prior ultrasound imaging before the procedure the particle was clearly not visible in the patient's left atrium.The physician inspected the agilis and brk after extraction and did not notice any defect.The procedure was finished as planned and the patient was stable and sent to the icu for further observation.The particle not retrieved, as it was hoped it was a thrombus that could be heparinized.Following procedure, the patient was anticoagulated, and the particle was not visible the next day, thus the physician says it was a thrombus.The patient is stable and was dismissed from the hospital.

Manufacturer Narrative

One brk transseptal needle/stylet assembly were received for evaluation.No visual anomalies were noted.No resistance or functional anomalies were noted when the returned brk needle/stylet assembly was advanced through the returned dilator/sheath assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported patient thrombus remains unknown.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 98 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: 16244856
• MDR Text Key: 308144802
• Report Number: 3008452825-2023-00031
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205191
• UDI-Public: 05414734205191
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G407212
• Device Catalogue Number: G407212
• Device Lot Number: 8505193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: AGILIS NXT STEERABLE INTRODUCER
• Patient Outcome(s): Other