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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES MICRO INTRODUCER SHEATH SET 7F X 7CM VNUS; CLOSUREFAST
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ARGON MEDICAL DEVICES MICRO INTRODUCER SHEATH SET 7F X 7CM VNUS; CLOSUREFAST Back to Search Results
Model Number MIS-7F07
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The sample device is indicated as available for evaluation.Argon has made three requests for the return of the sample, the last request was sent on 4/29/2020.A follow-up report will be provided when more information is available.
 
Event or Problem Description
Physician was attempting to use micro introducer dialator.It was reported that the catheter broke and physician could not get it to work/stop working.There was no patient injury reported.
 
Event or Problem Description
Follow up.
 
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Brand Name
MICRO INTRODUCER SHEATH SET 7F X 7CM VNUS
Common Device Name
CLOSUREFAST
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
MDR Report Key10014005
Report Number1625425-2020-00313
Device Sequence Number16847349
Product Code DRE
UDI-Device Identifier10884521140295
UDI-Public10884521140295
Combination Product (Y/N)N
Initial Reporter StateCA
PMA/510(K) Number
K780126
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) 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/23/2024
Device Model NumberMIS-7F07
Device Catalogue NumberMIS-7F07
Device Lot Number11284802
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date04/30/2020
Supplement Report FDA Received Date06/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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