MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE, 89 CM LENGTH; TROCAR

Model Number G407215

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer reference: 3005334138-2020-00235, 3005334138-2020-00261, 3008452825-2020-00329.During a procedure, resistance was noted while trying to advance the brk needle.Force was needed to advance the device.The sheath and needle were replaced, and again the issue was noted.The devices were replaced a third time and resolution was found to complete the procedure.There were no patient consequences.No additional access site was required, however a clinically significant delay of 20-30 minutes was noted.

Manufacturer Narrative

One brk-1¿ transseptal needle, 89 cm length was received for investigation.The needle had been bent.The needle/stylet assembly was inserted into an 8.5f sl1 sheath/dilator assembly from current inventory.Resistance was noted due to the aforementioned damage to the needle.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 bend in the needle and subsequent needle insertion difficulty remains unknown.

• Brand Name: BRK-1 TRANSSEPTAL NEEDLE, 89 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
• MDR Report Key: 10204362
• MDR Text Key: 196775296
• Report Number: 3008452825-2020-00330
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734207225
• UDI-Public: 05414734207225
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: G407215
• Device Catalogue Number: G407215
• Device Lot Number: 6722664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK-1¿ TRANSSEPTAL NEEDLE.; SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER (X2).
• Patient Outcome(s): Other
• Patient Age: 44 YR