MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM

Model Number	MIS-7F07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a micro introducer kit with the 45cm.018¿ guidewire from mis-7f07 kit during treatment of the patients left proximal great saphenous vein (gsv).Minimal vessel tortuosity was reported.Vein diameter reported as 32mm.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.The lumen was flushed prior to use.Tumescent infiltration was not utilized.No anesthesia was utilized.No compression was used.No resistance was encountered when advancing the device.Removal difficulties were reported.Access to vein occurred without resistance but when the introducer, dilator and sheath were removed, there was no resistance but provider noticed the floppy part of the introducer access wire was left behind in the vein when viewed under ultrasound.Procedure was aborted.
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.One used guidewire was returned to argon from the customer.A visual inspection was performed on the returned sample.The visual inspection determined that the guidewire is broken on the distal end.There was no coil attached.It is possible that this may be related to a similar a known issue.Since the manufacture of this lot, capa actions from capa-00040 have been implemented to mitigate the guidewire breakage issue.The capa will identify the specific root causes and corrective actions to be taken.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM
• Common Device Name: CLOSUREFAST
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19314648
• Report Number: 0001625425-2024-01024
• Device Sequence Number: 19602269
• Product Code: DRE
• UDI-Device Identifier: 00886333227532
• UDI-Public: (01)00886333227532(17)281129(10)11507188
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MIS-7F07
• Device Lot Number: 11507188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/15/2024; 09/01/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/14/2024; 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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