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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After three notifications, a sample for this complaint has not been returned for review.However, an image was provided that shows the hub of the dilator to be detached from the dilator shaft.Based on the image and previous complaints regarding this issue, this complaint was confirmed.Capa (b)(4) has been initiated to investigate the dilator issue.The capa will document the root causes identified and the corrective actions taken to address the issue.
Event or Problem Description
Physician intended to use a micro introducer kit with a closurefast catheter along with rfg3 during treatment of the entire length of great saphenous vein (gsv).Ifu was followed.Guide wire was used for the insertion of catheter.Proper temperature was reached.It was reported that the micro introducer separated when removing device during procedure.There was no patient injury reported.
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: 10113108
• Report Number: 1625425-2020-00330
• Device Sequence Number: 2561634
• Product Code: DRE
• UDI-Device Identifier: 10884521140295
• UDI-Public: 10884521140295
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/26/2020

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 Date: 12/17/2024
• Device Model Number: MIS-7F07
• Device Catalogue Number: MIS-7F07
• Device Lot Number: 11288390
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1