MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 1S ONESTIC MICRO-ACCESS INTRODUCER 5F

Model Number	497830
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2022
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
When using a syringe to flush the vascular sheath with saline during the operation, it was found that the catheter was blocked, so a new vascular sheath was replaced to complete the operation.
Additional Manufacturer Narrative
The sample is indicated as returned.As of this date, sample evaluation has not been completed.A follow-up will be submitted once the sample has been evaluated.
Event or Problem Description
When using a syringe to flush the vascular sheath with saline during the operation, it was found that the catheter was blocked, so a new vascular sheath was replaced to complete the operation.
Event or Problem Description
When using a syringe to flush the vascular sheath with saline during the operation, it was found that the catheter was blocked, so a new vascular sheath was replaced to complete the operation.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One opened device was returned for review from the customer.A visual and functional inspection was performed on the returned product.The visual inspection did not find any external damage to the devices.The dilator and introducer were both flushed with a water-filled syringe and the devices flushed as designed and no blockage was found during the functional test.Since the failure mode could not be duplicated, no corrective action will be implemented.

• Brand Name: 1S ONESTIC MICRO-ACCESS INTRODUCER 5F
• Common Device Name: 1S ONESTIC MICRO-ACCESS INTRODUCER 5F
• 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: 13659900
• Report Number: 0001625425-2022-00957
• Device Sequence Number: 6229063
• Product Code: DRE
• UDI-Device Identifier: 00886333223893
• UDI-Public: 00886333223893
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2022

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
• Device Expiration Date: 07/27/2024
• Device Model Number: 497830
• Device Catalogue Number: 497830
• Device Lot Number: 11379145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/25/2022
• Supplement Date Received by Manufacturer: 02/25/2022; 02/25/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/11/2022; 05/03/2022
• 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