MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ATRIEVE VASCULAR SNARE KIT 3.2FR

Model Number	381003008
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
During use, the physician attempted to insert the snare into the delivery catheter with using the introducer, however, the snare got stucked and unable to advance.Then the physician attempted to insert the snare to the delivery catheter from the distal tip of the delivery catheter, but the snare got stucked again.Unable to set the snare in the delivery catheter.The atrieve was switched to another new one and the procedure was completed.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been investigated and reviewed.
Event or Problem Description
During use, the physician attempted to insert the snare into the delivery catheter with using the introducer, however, the snare got stucked and unable to advance.Then the physician attempted to insert the snare to the delivery catheter from the distal tip of the delivery catheter, but the snare got stucked again.Unable to set the snare in the delivery catheter.The atrieve was switched to another new one and the procedure was completed.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One unsealed atrieve was returned for review by the customer.A visual and dimensional inspection was performed on the returned product.The visual inspection established that there was no external damage found on the device during the investigation.The part was measured on several places such as the proximal, middle, distal, taper, and solder.The measurements were within specification according to drawings.With only the atrieve returned the delivery catheter sheathe cannot be checked for any defects.Since there was no issue observed during the investigation, no corrective action will be done at this time.
Event or Problem Description
During use, the physician attempted to insert the snare into the delivery catheter with using the introducer, however, the snare got stucked and unable to advance.Then the physician attempted to insert the snare to the delivery catheter from the distal tip of the delivery catheter, but the snare got stucked again.Unable to set the snare in the delivery catheter.The atrieve was switched to another new one and the procedure was completed.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 3.2FR
• Common Device Name: ATRIEVE
• 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: 12965712
• Report Number: 0001625425-2021-01208
• Device Sequence Number: 11925129
• Product Code: MMX
• UDI-Device Identifier: 20886333003963
• UDI-Public: 20886333003963
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2026
• Device Model Number: 381003008
• Device Catalogue Number: 381003008
• Device Lot Number: 11351925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 11/30/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/04/2022; 05/20/2022
• 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