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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Physician intended to use a micro introducer kit during treatment of patients great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Tumescent infiltration was utilized.Local anesthesia was used.Compression was not used.It is reported the access wire broke.Physician was able to retrieve it with a ¼ incision.Procedure was completed by using varithena.1 segment was treated and vein is reported to have closed.No further patient injury reported.
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Images were provided.A follow-up report will be submitted once the images have been investigated.
Event or Problem Description
Physician intended to use a micro introducer kit during treatment of patients great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Tumescent infiltration was utilized.Local anesthesia was used.Compression was not used.It is reported the access wire broke.Physician was able to retrieve it with a ¼ incision.Procedure was completed by using varithena.1 segment was treated and vein is reported to have closed.No further patient injury reported.
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.As part of the capa process, a mdt/argon root cause investigation team was assembled.An evaluation of the internal records was performed, discussion was conducted with wire manufacturer and supplier engineering change orders were also reviewed for the last five years.There were no non-conformance found based on metallurgy and no engineering changes identified.A definite root cause was not identified for this failure mode and no immediate corrections were made due to absence of initial root cause identification.Several action items have been planned to be implemented to address this reported event.Tensile test will be implemented per test method, retraining program and certification program plan for polishing silver soldering will be put in place.If new information is available in future, a follow-up report will be submitted accordingly.

• Brand Name: CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM
• Common Device Name: CLOSUREFAST MICRO INTRODUCER SHEATH SET
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 16501804
• Report Number: 0001625425-2023-00993
• Device Sequence Number: 20381052
• Product Code: DRE
• UDI-Device Identifier: 10884521140295
• UDI-Public: 10884521140295
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023
• 2 Devices were Involved in the Event: 1 2

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: 11448885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown