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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES COAXIAL SABD BIOPSY DEVICE 20GA
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ARGON MEDICAL DEVICES COAXIAL SABD BIOPSY DEVICE 20GA Back to Search Results
Model Number CS-2015-15
Device Problem Break (1069)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The tip of the biopsy needle broke off during use in the patient and remained in the tumor.The tumor was later completely excised (with the tip of the biopsy needle).A sabd was returned as well as a cs needle.It is unclear which needle is affected by the complaint.
 
Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
 
Manufacturer Narrative
The required notch thickness in the sampling area is 0.0120".The notch thickness in this area on the failed device is.0098" or 0.0022" u/min.This reduction in material thickness in the notched area will increase the probability of breakage, however, the increase in probability would have to be quantified via experimentation.The notch thickness on the second, undamaged, device returned measured 0.0120" which equals the target dimension for this feature.The returned, defective sample has a sharp curvature at the distal end where the stylet tip broke off.The break appears to have occurred at the radius formed between the tip and the notched area.It is possible rapid wrist flipping of the device in an attempt to free the stylet tip emulated cyclic loading and lead to fracture.A definitive root cause was not identified during investigation and a corrective action was not possible to be implemented without a root cause.This event will be re investigated if new information becomes available in the future.
 
Event Description
The tip of the biopsy needle broke off during use in the patient and remained in the tumor.The tumor was later completely excised (with the tip of the biopsy needle).A sabd was returned as well as a cs needle.It is unclear which needle is affected by the complaint.
 
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Brand Name
COAXIAL SABD BIOPSY DEVICE 20GA
Type of Device
COAXIAL SABD
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key17799038
MDR Text Key324041937
Report Number0001417485-2023-00003
Device Sequence Number1
Product Code KNW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011270
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/20/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCS-2015-15
Device Lot Number11444819
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/01/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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