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

Model Number 380911120

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 290561307
• Report Number: 0001625425-2022-00931
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 00886333224609
• UDI-Public: 00886333224609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other