MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 6F MICRO INTRODUCER SET 7CM VNUS

Model Number	MIS-6F07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Event or Problem Description
It was reported that an attempt was made to use a mis-7f07 to treat a lesion.The lumen was flushed prior to use.Ifu was followed.A guidewire was not used for the insertion of the catheter.Guidewire sheared off and fractured in the patients vein.Case aborted.All pieces accounted for.Patient will return on a future date to complete case.No patient injury reported.
Additional Manufacturer Narrative
Udi related data quality updates only.Corrected information provided in d.4.

• Brand Name: 6F MICRO INTRODUCER SET 7CM VNUS
• Common Device Name: INTRODUCER SET
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18333121
• Report Number: 0001625425-2023-01280
• Device Sequence Number: 15555328
• Product Code: DRE
• UDI-Device Identifier: 10884521140295
• UDI-Public: (01)10884521140295(17)280918(10)11497809
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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 Model Number: MIS-6F07
• Device Lot Number: 11497809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown