MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ATRIEVE VASCULAR SNARE KIT 6FR

Model Number	382006015
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the pre-test the function of the atrieve¿ vascular snare is ok, but when the operators were putting the atrieve¿ vascular snare in the vessel they found the coil was keeping falling from the loop, so the operator just immediately took the atrieve¿ vascular snare out.Because this patient's condition is unstable and very bad, so they couldn't continuous use another new vascular snare to take those falling coils out.The physician is very upset about the falling coils.Please noted the falling coils are still left in this patient's vessel now.
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.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
During the pre-test the function of the atrieve¿ vascular snare is ok, but when the operators were putting the atrieve¿ vascular snare in the vessel they found the coil was keeping falling from the loop, so the operator just immediately took the atrieve¿ vascular snare out.Because this patient's condition is unstable and very bad, so they couldn't continuous use another new vascular snare to take those falling coils out.The physician is very upset about the falling coils.Please noted the falling coils are still left in this patient's vessel now.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One used atrieve was returned to argon from the customer.A visual inspection was performed on the returned product.The visual inspection established that the nitinol wire was bunched up in bundles at the ends of the loops.Upon closer look, it seems that the nitinol wire was broken near the base.The damage looks consistent with the snare being pulled using excessive force during retrieval.The complaint description mentions that the snare looked okay prior to use, so it is likely that the damage happened as a result of an event within the user's environment and not a manufacturing issue.Since the damage is likely to happen as a result of an event within the user's environment, no corrective action will be implemented at this time.
Event or Problem Description
During the pre-test the function of the atrieve¿ vascular snare is ok, but when the operators were putting the atrieve¿ vascular snare in the vessel they found the coil was keeping falling from the loop, so the operator just immediately took the atrieve¿ vascular snare out.Because this patient's condition is unstable and very bad, so they couldn't continuous use another new vascular snare to take those falling coils out.The physician is very upset about the falling coils.Please noted the falling coils are still left in this patient's vessel now.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 6FR
• Common Device Name: ATRIEVE VASCULAR SNARE 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: 14976766
• Report Number: 0001625425-2022-01039
• Device Sequence Number: 5689866
• Product Code: MMX
• UDI-Device Identifier: 20886333004021
• UDI-Public: 20886333004021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021606
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2022

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 Expiration Date: 05/19/2026
• Device Model Number: 382006015
• Device Catalogue Number: 382006015
• Device Lot Number: 11366313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 07/05/2022; 07/05/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/29/2022; 09/12/2022
• 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