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 Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Foreign Body In Patient (2687)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
Physician attempted to use a micro introducer kit during treatment of patients short saphenous vein (ssv).The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Tumescent infiltration was not utilized.Local anesthesia was used.Compression was not used.It is reported during access, the wire was cut off into patient vein.Vein size was very small.Physician tried to access above vein however it went into spasm.The procedure was aborted.Patient is rescheduled for (b)(6) 2023 for venaseal procedure to same ssv.
Event or Problem Description
The wire was cut off into patient vein.Vein size was very small.Physician tried to access above vein however it went into spasm.The procedure was aborted.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One used sample was returned for review.A visual inspection was performed on the returned product.The visual inspection established 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-conformances 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: 16598685
• Report Number: 0001625425-2023-01005
• Device Sequence Number: 12156975
• 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

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: 11451901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2022
• 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: Other; Required Intervention
• Patient Sex: Unknown