MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 6F PCI KIT/4 PERCUTANEOUS CATHETER INTRODUCER

Model Number	A496162
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
During procedure right after a placement of the introducer sheath in vessel, a physician found blood leak from the hemostasis valve.The product was replaced with an additionally opened a496162, and the procedure was completed.
Additional Manufacturer Narrative
A review of the dhr and inspection records could not be conducted since there was no lot number provided by the customer.One opened sample was returned for review from the customer.A functional test was performed on the returned sample.The inspection established that the introducer with the side port and the stopcock showed no visible external damage.The parts were flushed with water, colored water and there was no leakage found in the side port or the dilator during the time of inspection.The failure could not be duplicated.Since the failure mode could not be duplicated, no root cause or corrective action is necessary at this time.
Event or Problem Description
During procedure right after a placement of the introducer sheath in vessel, a physician found blood leak from the hemostasis valve.The product was replaced with an additionally opened a496162, and the procedure was completed.
Event or Problem Description
During procedure right after a placement of the introducer sheath in vessel, a physician found blood leak from the hemostasis valve.The product was replaced with an additionally opened a496162, and the procedure was completed.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been reviewed.

• Brand Name: 6F PCI KIT/4 PERCUTANEOUS CATHETER INTRODUCER
• Common Device Name: 6F PCI 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: 13082509
• Report Number: 0001625425-2021-01235
• Device Sequence Number: 14669303
• Product Code: DRE
• UDI-Device Identifier: 00886333216352
• UDI-Public: 00886333216352
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2022

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: A496162
• Device Catalogue Number: A496162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 12/10/2021; 12/10/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/07/2022; 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown