MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TSX TRANSSEPTAL NEEDLE; TROCAR

Catalog Number M004TSX100

Device Problems Complete Blockage (1094); Unintended Collision (1429)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2016

Event Type  malfunction  

Event Description

Tsx needle was inserted into swartz sheath/dilator outside the body resulting in impingement and producing plastic shavings clogging transseptal needle tip and sheath/dilator tip.The needle was unable to pass through the sheath.The physician used a different method to get the needle through.The sheath was given to the company for further investigation.

• Brand Name: TSX TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 65 great valley pkwy.; malvern PA 19355
• MDR Report Key: 6141129
• MDR Text Key: 61354621
• Report Number: 6141129
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: M004TSX100
• Device Lot Number: Q1000303
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2016
• Event Location: Other
• Date Report to Manufacturer: 11/17/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR