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

Model Number G407208

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an atrial fibrillation ablation procedure, the tip of the transseptal needle detached inside the patient.Right femoral vein access was achieved and the transseptal needle was advanced along with the sheath with no difficulties.As the transseptal puncture was being performed, it was believed that the needle had passed into the left atrium as tenting of the septum was no longer noted on imaging, however the tip of the needle was no longer visable.A guidewire was inserted but could not be advanced to the tip of the needle.The transseptal needle was then removed from the patient and it was noted that the distal tip was missing.Approximately 1.5 cm of the device could then be seen on imaging, appearing outside of the heart in the low part of the pulmonary vein.The patient was taken to the operating room for open heart surgery, but this was unsuccessful as the detached portion of the needle could not be located.The patient is currently being monitored in the intensive care unit.

Manufacturer Narrative

One brk transseptal needle was received for evaluation.The distal tip of the needle assembly had been fractured and detached proximal to the distal tip.The needle tip was not returned.The needle was bent in multiple locations.No other visual anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the fractured needle remains unknown.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TROCAR
• 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
• MDR Report Key: 9466397
• MDR Text Key: 170716553
• Report Number: 3008452825-2019-00634
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205139
• UDI-Public: 05414734205139
• Combination Product (y/n): N
• PMA/PMN Number: K122587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: G407208
• Device Catalogue Number: G407208
• Device Lot Number: 6979924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening