MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SINGLE-LOOP SNARE RETRIEVAL KIT

Model Number	380911120
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
After they snared the filter with the retrieval kit snare, the doctor sinched the filter into the 9fr sheath.The doctor then sheathed down over the filter with the 11fr sheath and retrieved the filter.Then the doctor pushed some contrast in the 11fr sheath for a final cavagram, and it looked good.Then when he pulled the 11fr sheath out it had a string of the inner sheath attached to the end of the 11fr sheath.It was removed from the patient without incident.

• Brand Name: SINGLE-LOOP SNARE RETRIEVAL KIT
• Common Device Name: RETRIEVAL 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: 13280433
• Report Number: 0001625425-2022-00931
• Device Sequence Number: 12030998
• Product Code: MMX
• UDI-Device Identifier: 00886333224609
• UDI-Public: 00886333224609
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191758
• 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
• Report Date (Section B): 01/18/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 380911120
• Device Catalogue Number: 380911120
• 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: 01/11/2022
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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