MAUDE Adverse Event Report: MEDTRONIC BROCKENBROUGH CURVED NEEDLE; TROCAR

Device Problems Contamination (1120); Obstruction of Flow (2423); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

During the procedure, as the guidewire was introduced into the dilator of the sheath, there was resistance felt like there was something blocking the inside.When the guidewire was removed, shaving of plastic were present.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BROCKENBROUGH CURVED NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17528848
• MDR Text Key: 321155680
• Report Number: MW5135776
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1