MAUDE Adverse Event Report: CAREFUSION COAXIAL TEMNO EVOLUTION; BIOPSY NEEDLE

Model Number CTT2015

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 01/30/2018

Event Type  Injury  

Event Description

During a long biopsy procedure of the upper lobe left side the product failed to deploy and was stuck.The doctor performing the procedure has to use a laceration kit to remove the product from the patient.

• Brand Name: COAXIAL TEMNO EVOLUTION
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION; chicago IL 60673
• MDR Report Key: 7233693
• MDR Text Key: 98846028
• Report Number: MW5074998
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: CTT2015
• Device Lot Number: 0001141884
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 98