MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLOSUREFAST MICRO PUNCTURE KIT 4FR/CH (1.3MM)

Model Number	MPK-4F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician was attempting to use a micro introducer sheath for treatment of the great saphenous vein (gsv).The ifu was followed.It was reported while accessing the vein, the physician noticed that the wire tip was already pre bent.The physician decided to access and believes that the bent wire tip grabbed onto a vein valve and broke off into the patient.It was decided to go forward with the ablation to go ahead a close off the vein, that way the piece of the wire could not travel into the deep venous system.Ablation was complete successfully and patient was scheduled with vascular surgery to have wire tip removed.That procedure was done successfully and no patient injury was reported.Physician is not comfortable using sheaths from that lot number and is requesting all 75 be replaced.
Additional Manufacturer Narrative
Sample is not available for return and investigation.Argon is investigating this event and a follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.According to the product experience report, sample not available to returned and the complaint was not confirmed, so no corrective action is required at this time.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
Event or Problem Description
A physician was attempting to use a micro introducer sheath for treatment of the great saphenous vein (gsv).The ifu was followed.It was reported while accessing the vein, the physician noticed that the wire tip was already pre bent.The physician decided to access and believes that the bent wire tip grabbed onto a vein valve and broke off into the patient.It was decided to go forward with the ablation to go ahead a close off the vein, that way the piece of the wire could not travel into the deep venous system.Ablation was complete successfully and patient was scheduled with vascular surgery to have wire tip removed.That procedure was done successfully and no patient injury was reported.Physician is not comfortable using sheaths from that lot number and is requesting all 75 be replaced.
Additional Manufacturer Narrative
Udi related data quality updates only.Corrected information provided in d.4.

• Brand Name: CLOSUREFAST MICRO PUNCTURE KIT 4FR/CH (1.3MM)
• Common Device Name: CLOSUREFAST MICRO PUNCTURE KIT
• 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: 17858242
• Report Number: 0001625425-2023-01208
• Device Sequence Number: 5429273
• Product Code: DRE
• UDI-Device Identifier: 10884521140370
• UDI-Public: (01)10884521140370(17)271118(10)11449667
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: ENFORCEMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024
• 2 Devices were Involved in the Event: 1 2

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: MPK-4F
• Device Lot Number: 11449667
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 07/08/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/09/2023; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown