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U.S. Department of Health and Human Services

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

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MERIT MEDICAL SYSTEMS INC. COAXIAL BIOPSY NEEDLE BIOPSY NEEDLE, Back to Search Results
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.
 
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Brand NameCOAXIAL BIOPSY NEEDLE
Type of DeviceBIOPSY 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 Key7866490
MDR Text Key119927849
Report Number1721504-2018-00097
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
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 Received09/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCTT1815
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 Received08/14/2018
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 Treatment Data
Date Received: 09/11/2018 Patient Sequence Number: 1
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