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

Model Number	407201
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, when pulling back the syringe to flush needle, air entered the syringe.The needle was replaced, and the procedure was completed with no adverse patient consequences.
Additional 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.
Additional Manufacturer Narrative
Two brk transseptal needles were received for evaluation.Both brk needles were flushed with the sideport opened; no leak was noted.When the sideport was closed no air retracted into the syringe.No functional anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported needle leak remains unknown.

• Brand Name: BRK-1 TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Common Device Name: 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: 11298721
• Report Number: 3008452825-2021-00018
• Device Sequence Number: 729424
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 7697661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 03/01/2021; 04/29/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/01/2021; 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1