MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. BRK-1; TROCAR

Model Number XS SERIES

Device Problem Failure to Advance (2524)

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

Event Date 05/13/2020

Event Type  malfunction  

Event Description

Stylet in the brk-1 xs needle was removed to flush the needle and when the tech attempted to replace the stylet it would not pass through the needle.A second transseptal needle was tried with the same lot number (7346292) with the same result.Both needles were removed from the sterile field and a 3rd needle was pulled with a different lot number was used without any issues.

• Brand Name: BRK-1
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau pl.; minnetonka MN 55345
• MDR Report Key: 10791818
• MDR Text Key: 214801451
• Report Number: 10791818
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XS SERIES
• Device Catalogue Number: G407212
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA