MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1 XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number G407209

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes, along with investigation results will be provided in a subsequent submission.

Event Description

During the procedure, the proximal portion of the needle detached.The needle was exchanged to continue the procedure with no consequences to the patient.

Manufacturer Narrative

One brk transseptal needle was received for evaluation.The stopcock was no longer attached to the needle assembly.The needle retaining clip was noted to be detached from the stopcock and not returned.The needle stopcock was able to be reattached with a retaining clip from inventory with no functional anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of ¿the proximal portion of the needle was detached¿ is consistent with the detached retaining clip.Based on the received condition of the device and the information provided, the cause of the detached retaining clip remains unknown.

• Brand Name: BRK-1 XS 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
• MDR Report Key: 10852682
• MDR Text Key: 218572610
• Report Number: 3008452825-2020-00652
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: 05414734205184
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: G407209
• Device Catalogue Number: G407209
• Device Lot Number: 7449724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1