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	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the product experience report, sample is not available for return.Argon is investigating this reported event and a follow-up report will be submitted upon investigation completion.
Event or Problem Description
Physician attempted to use a micro introducer kit during patient treatment.The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.It was reported the valve stayed open when they pulled out the dilater and 018 wire before they put the catheter in and the patient bleed everywhere.A replacement mis-7f07 kit was used to complete procedure.No additional treatment required.No patient injury reported.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.Since this is a known issue the complaint was confirmed.Capa ca-00058 has been initiated to address the introducer leakage issue.The capa will document the root cause identified and the corrective action that was taken to address the issue.
Event or Problem Description
Physician attempted to use a micro introducer kit during patient treatment.The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.It was reported the valve stayed open when they pulled out the dilater and 018 wire before they put the catheter in and the patient bleed everywhere.A replacement mis-7f07 kit was used to complete procedure.No additional treatment required.No patient injury reported.
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 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: 18308008
• Report Number: 0001625425-2023-01263
• Device Sequence Number: 17838654
• Product Code: DRE
• UDI-Device Identifier: 10884521140295
• UDI-Public: (01)10884521140295(17)280815(10)11493083
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 07/21/2024

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: 11493083
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 07/08/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 05/17/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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