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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. ENDOMYOCARDIAL BIOPSY FORCEP DEVICE, BIOPSY, ENDOMYOCARDIAL

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ARGON MEDICAL DEVICES, INC. ENDOMYOCARDIAL BIOPSY FORCEP DEVICE, BIOPSY, ENDOMYOCARDIAL Back to Search Results
Device Problems Break (1069); Malposition of Device (2616)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/28/2018
Event Type  malfunction  
Event Description
Reportedly, during a myocardial biopsy when inserting the argon biopsy forcep into the sheath and while squeezing the handle to get a piece of the right ventricle, the spring in the handle snapped leaving the forceps in the open position. An x-ray was used to help remove the forceps, given the forcep was stuck in an open position. Reportedly, all the pieces were recovered and the forceps were able to be removed. No patient harm reported.
 
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Brand NameENDOMYOCARDIAL BIOPSY FORCEP
Type of DeviceDEVICE, BIOPSY, ENDOMYOCARDIAL
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek rd.
athens TX 75751
MDR Report Key7446217
MDR Text Key106023907
Report Number7446217
Device Sequence Number1
Product Code DWZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/16/2018,04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2018
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberFORCEP BIOPSY 2.4MM X 50CM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/16/2018
Event Location Hospital
Date Report to Manufacturer04/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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