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	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Foreign Body In Patient (2687)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is not available for return.An image was provided for investigation.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Physician attempted to use a micro introducer kit during treatment of patients great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Local anesthesia was used.Hand compression was used.Physician accessed the patient's gsv and inserted the wire and sheath with no resistance or any issues whatsoever.Physician then went to move the sheath back and the entire shaft (white part of sheath) came apart while inside the patient.The physician and the ultrasound tech scanned throughout the entire leg, which physician commented had great visualization.Physician also mentioned the patient was really tall and no anatomical issues or large body habitus.This happened in the beginning of the procedure before tumescent.They were unable to locate any object in the patients vein and then searched the entire room (bed, floor, everywhere) to locate the missing piece but were not able to find it anywhere.It is presumably inside the patient.The physician then pulled another sheath and completed the procedure without any issues.There is still no answer as to where this piece went.1 segment was treated and the vein is reported to have closed.The second sheath used in the procedure was from the same lot and after physician pulled it out at the end of procedure, physician demonstrated how easily the second one came apart.Patient was fine during and after the procedure and will return for a follow up ultrasound.Patient had follow up ultrasound on 11/8 and was doing fine.Still unsure where sheath went and physician plans to do further observations to try and locate.
Event or Problem Description
Physician attempted to use a micro introducer kit during treatment of patients great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Local anesthesia was used.Hand compression was used.Physician accessed the patient's gsv and inserted the wire and sheath with no resistance or any issues whatsoever.Physician then went to move the sheath back and the entire shaft (white part of sheath) came apart while inside the patient.The physician and the ultrasound tech scanned throughout the entire leg, which physician commented had great visualization.Physician also mentioned the patient was really tall and no anatomical issues or large body habitus.This happened in the beginning of the procedure before tumescent.They were unable to locate any object in the patients vein and then searched the entire room (bed, floor, everywhere) to locate the missing piece but were not able to find it anywhere.It is presumably inside the patient.The physician then pulled another sheath and completed the procedure without any issues.There is still no answer as to where this piece went.1 segment was treated and the vein is reported to have closed.The second sheath used in the procedure was from the same lot and after physician pulled it out at the end of procedure, physician demonstrated how easily the second one came apart.Patient was fine during and after the procedure and will return for a follow up ultrasound.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.There was no physical samples returned to argon from the customer however, there was an image provided.Based on the image provided by the customer the complaint was confirmed.Capa ca-00057 has been initiated to address the detached introducer issue.The capa will document the root cause identified and the corrective action that was taken to address the issue.

• 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: 18253149
• Report Number: 0001625425-2023-01247
• Device Sequence Number: 7108114
• Product Code: DRE
• UDI-Device Identifier: 10884521140295
• UDI-Public: (01)10884521140295(17)280731(10)11489175
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/19/2024

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: 11489175
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 11/10/2023; 07/08/2024
• Initial Report FDA Received Date: 12/01/2023
• 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: 08/01/2023
• 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; Required Intervention
• Patient Sex: Unknown