MAUDE Adverse Event Report: ARGON MEDICAL DEVICES MICRO INTRODUCER SHEATH SET 7F X 7CM VNUS; CLOSUREFAST

Model Number	MIS-7F07
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is indicated as available for evaluation.As of the date of this report, the device has not yet been returned.A follow-up report will be provided once it has been received and reviewed.
Event or Problem Description
Physician intended to use a 7fr micro introducer sheath during treatment of the patient¿s great saphenous vein (gsv).It is reported the white tube part of the introducer sheath snapped off into the vein when the blue introducer was removed.The device was removed from the patient and all pieces were accounted for.A new micro introducer sheath was opened and used to complete the procedure.No injury reported.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text : placeholder.
Event or Problem Description
Follow up.

• 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 Key: 10513427
• Report Number: 1625425-2020-00511
• Device Sequence Number: 3507138
• Product Code: OFL
• UDI-Device Identifier: 10884521140295
• UDI-Public: 10884521140295
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2020

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 Model Number: MIS-7F07
• Device Catalogue Number: MIS-7F07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/02/2020; 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1