MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 7F ONESTIC MICRO-ACCESS INTRODUCER

Model Number	497847
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sample not available for return.A follow-up report will be submitted once investigation completes.
Event or Problem Description
A physician used an introducer kit 7f during a procedure.The device was inspected with no issues noted.The device was prepped per the ifu, with no issues identified.The doctor has indicated that the guide that comes in the introducer pack is very flimsy, navigates very poorly.During the procedure the guide broke and remained inside, it could be rescued without major problems.This pack with this 0.018" and 45 cm in length guide generates insecurity during the procedure and they do not feel comfortable using it.No patient injury reported.
Event or Problem Description
A physician used an introducer kit 7f during a procedure.The device was inspected with no issues noted.The device was prepped per the ifu, with no issues identified.The doctor has indicated that the guide that comes in the introducer pack is very flimsy, navigates very poorly.During the procedure the guide broke and remained inside, it could be rescued without major problems.This pack with this 0.018" and 45 cm in length guide generates insecurity during the procedure and they do not feel comfortable using it.No patient injury reported.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.No samples or images were returned by the customer for review.However, this is more than likely related to a known issue.Capa ca-00040 has been initiated to address the broken guidewire issue, and the capa will identify the specific causes and corrective actions to be taken.As part of the capa process, a mdt/argon root cause investigation team was assembled.An evaluation of the internal records was performed, discussion was conducted with wire manufacturer and supplier engineering change orders were also reviewed for the last five years.There were no non-conformances found based on metallurgy and no engineering changes identified.A definite root cause was not identified for this failure mode and no immediate corrections were made due to absence of initial root cause identification.Several action items have been planned to be implemented to address this reported event.Tensile test will be implemented per test method, retraining program and certification program plan for polishing silver soldering will be put in place.If new information is available in future, a follow-up report will be submitted accordingly.

• Brand Name: 7F ONESTIC MICRO-ACCESS INTRODUCER
• Common Device Name: INTRODUCER
• 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: 16546518
• Report Number: 0001625425-2023-01000
• Device Sequence Number: 6389161
• Product Code: DRE
• UDI-Device Identifier: 00886333224661
• UDI-Public: 00886333224661
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 497847
• Device Catalogue Number: 497847
• Device Lot Number: 11446086
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: Other; Required Intervention
• Patient Sex: Unknown