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	Difficult to Advance (2920)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Event or Problem Description
A micro introducer sheath was to be used during treatment of the great saphenous vein (gsv).The physician noticed 5 sheaths that were extremely difficult to push the catheter through the sheath.The ifu was followed.Physician concerned that the catheter could kink or break off, once forced catheter through and a "pop" was felt and an abnormal amount of blood loss occurred through the valve of the sheath.The procedure was finished using the sheath but the blood loss was not normal.The device is not available for return as it was discarded.
Additional Manufacturer Narrative
Udi related data quality updates only.Corrected information provided in d.4.

• Brand Name: CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM
• Common Device Name: CLOSUREFAST MICRO INTRODUCER
• 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: 18464928
• Report Number: 0001625425-2024-00919
• Device Sequence Number: 2984058
• Product Code: DRE
• UDI-Device Identifier: 00886333227532
• UDI-Public: (01)00886333227532(17)280918(10)11497809
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 11497809
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 09/01/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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