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

Model Number MIS-7F07

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2020

Event Type  malfunction  

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 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 Description

Follow up.

• Brand Name: MICRO INTRODUCER SHEATH SET 7F X 7CM VNUS
• Type of Device: CLOSUREFAST
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10014005
• MDR Text Key: 189753034
• Report Number: 1625425-2020-00313
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10884521140295
• UDI-Public: 10884521140295
• Combination Product (y/n): N
• PMA/PMN Number: K780126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MIS-7F07
• Device Catalogue Number: MIS-7F07
• Device Lot Number: 11284802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1