MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. COAXIAL BIOPSY NEEDLE BIOPSY NEEDLE,

Catalog Number CTT1815

Device Problems Mechanical Problem (1384); Defective Device (2588)

Patient Problem Pneumothorax (2012)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation. A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that during an attempted biopsy of a lung mass under ct guidance, the patient acquired a pneumothorax. The physician states that the needle was inserted into position within the targeted lung lesion when an attempt to insert the biopsy needle was made. The needle became lodged within the coaxial biopsy device. It was very difficult to advance or remove the needle. Manipulation of the device was required to extricate the needle from the patient. At this time the patient developed an immediate pneumothorax, preventing any further attempts to successfully complete the scheduled biopsy. The procedure was cancelled, and the patient was monitored for two weeks. The pneumothorax resolved on its own. A repeat biopsy procedure was scheduled for the patient.

• Brand Name: COAXIAL BIOPSY NEEDLE
• Type of Device: BIOPSY NEEDLE,
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 7866490
• Report Number: 1721504-2018-00097
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CTT1815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Hospitalization; Life Threatening