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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SCREW DILATOR
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ARGON MEDICAL DEVICES SCREW DILATOR Back to Search Results
Model Number 630838025
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 11/26/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device is indicated as available for evaluation.As of the date of this report, it has not yet been returned.A follow-up report will be provided once the device has been received and reviewed.
 
Event or Problem Description
In connection with drainage systems, a screw dilator is used over the guide wire.The tip of the dilator breaks and cannot be pulled out of the patient and must be left.
 
Event or Problem Description
Follow up.
 
Additional Manufacturer Narrative
H3 other text: placeholder.
 
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Brand Name
SCREW DILATOR
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
MDR Report Key10980107
Report Number1625425-2020-00789
Device Sequence Number728120
Product Code FGE
UDI-Device Identifier00886333004911
UDI-Public00886333004911
Combination Product (Y/N)N
PMA/510(K) Number
K990808
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/29/2023
Device Model Number630838025
Device Catalogue Number630838025
Device Lot Number11222897
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date12/09/2020
Supplement Report FDA Received Date01/14/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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