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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE
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ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE Back to Search Results
Model Number 701218150
Device Problems Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/08/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned, and evaluation is anticipated but had not yet begun.A follow-up report will be submitted once the device has been evaluated.
 
Event Description
1st pass.Physician pressed plunger to obtain specimen and device handle came apart.Did not obtain specimen.Patient started bleeding, nodule could not be seen due to bleeding and unable to pull another device to make a 2nd pass.
 
Event Description
1st pass.Physician pressed plunger to obtain specimen and device handle came apart.Did not obtain specimen.Patient started bleeding, nodule could not be seen due to bleeding and unable to pull another device to make a 2nd pass.
 
Manufacturer Narrative
Parts from an opened device was returned for evaluation.Visual inspection found no damage to the stylet and cannula, but without either half of the body to review, the alleged complaint could not be investigated.However, due to this issue being reported numerous times for this lot, the complaint was confirmed.Argon medical devices has received other complaints that the supercore semi-automatic biopsy instrument is coming apart during or prior to use.Argon has conducted an internal investigation and tracked the affected parts to a narrow time frame resulting from a specific manufacturing event.The plastic housing and plunger can be separated more easily than normal for the lots manufactured during this time frame.Capa 2021-061 has been opened to document our investigation into the cause of this problem and the corrective action that are being taken to ensure that this never happens again.To ensure continued customer satisfaction, argon medical devices has decided to issue a voluntary recall of the affected lots because of the high rate of reports of unintentional disassembly of these devices.
 
Manufacturer Narrative
The device was returned, and evaluation is anticipated but had not yet begun.A follow-up report will be submitted once the device has been evaluated.
 
Event Description
1st pass: physician pressed plunger to obtain specimen and device handle came apart.Did not obtain specimen.Patient started bleeding, nodule could not be seen due to bleeding and unable to pull another device to make a 2nd pass.
 
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Brand Name
SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE
Type of Device
SUPERCORE
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 Key12776170
MDR Text Key281509955
Report Number0001625425-2021-01114
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00886333005987
UDI-Public00886333005987
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number701218150
Device Catalogue Number701218150
Device Lot Number11383195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1625425-09/30/2021-001-R
Patient Sequence Number1
Patient Outcome(s) Other;
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