MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a micro introducer kit during rfa treatment of patients great saphenous vein (gsv) & anterior accessory great saphenous vein (aagsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.A guidewire was used for insertion of catheter.Tumescent infiltration was utilized.Hand compression was used.Physician accessed left below the knee gsv and as he was removing the dilator and wire, he noticed the microtip on the wire was missing.Physician scanned the leg with ultrasound and visualized the tip of the wire was partially in the vein and the remainder of the wire successfully came out of the body inside the sheath.Physician attempted to gain access to the wire tip but could not access the retained wire.All pieces are not accounted for.Procedure was completed with an rf catheter.The vein is reported to have closed.No additional treatment required.No patient injury reported.
Additional Manufacturer Narrative
The complaint sample was returned for evaluation and is currently being investigated.A follow-up report will be provided following the completion of the investigation.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.No sample was returned to argon for review.However, images were provided by the customer.The image confirms that the guidewire is broken.Capa ca-00040 has been initiated to address the broken guidewire issue, and the capa will identify the specific causes and corrective actions to be taken.
Event or Problem Description
Physician attempted to use a micro introducer kit during rfa treatment of patients great saphenous vein (gsv) & anterior accessory great saphenous vein (aagsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.A guidewire was used for insertion of catheter.Tumescent infiltration was utilized.Hand compression was used.Physician accessed left below the knee gsv and as he was removing the dilator and wire, he noticed the microtip on the wire was missing.Physician scanned the leg with ultrasound and visualized the tip of the wire was partially in the vein and the remainder of the wire successfully came out of the body inside the sheath.Physician attempted to gain access to the wire tip but could not access the retained wire.All pieces are not accounted for.Procedure was completed with an rf catheter.The vein is reported to have closed.No additional treatment required.No patient injury reported.
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: MICRO INTRODUCER SHEATH SET
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1455 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18292476
• Report Number: 0001625425-2023-01253
• Device Sequence Number: 17816748
• Product Code: DRE
• UDI-Device Identifier: 10884521140295
• UDI-Public: (01)10884521140295(17)280726(10)11487868
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: MIS-7F07
• Device Lot Number: 11487868
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/29/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 11/16/2023; 07/08/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 05/17/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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
• Patient Sex: Unknown