MAUDE Adverse Event Report: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION BRK-1; TROCAR

Model Number 407201

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

The transseptal needle was bent in the package.The product was removed and replaced with no harm to the patient.St.Jude brk-1 needle, ref: 407201, lot: 9153402, clinical site notified mfg rep directly.Manufacturer response for transseptal needle, st.Jude brk-1 needle transseptal needle (per site reporter).

• Brand Name: BRK-1
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL CARDIOVASCULAR DIVISION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 18621476
• MDR Text Key: 334309014
• Report Number: 18621476
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/04/2024

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 Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 9153402
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1