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

Model Number	382006020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The atrieve was opened to use for evar procedure.The stent graft going to use for evar was endurant by medtronic.A 7f/100cmguiding catheter parent from medikit was inserted to the patient from brachial artery.To pull though, the atrieve delivery catheter was inserted to the parent guiding catheter and placed in the target area.And then, the atrieve snare was inserted to the guiding catheter.At that time, the physician noticed that the radiopaque band on the tip of the delivery catheter had come off in the blood vessel.It became unable to confirm the placement of the tip of the delivery catheter without the radiopaque band, therefore, the delivery catheter and the snare was removed.After the procedure, it was confirmed the detached radiopaque band remained and stayed at th 9 inside of the patient.The patient is stable and additional treatment for the remaining radiopaque band in the patient has not been taken.
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.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One used sample was returned to argon from the customer.A visual inspection was performed on the returned sample.The visual inspection established that there was no radiopaque band on the delivery catheter sheathe.This may be due to the i.D.Of the radiopaque band being over tolerance during swaging.This would allow for possible cracking in the band which may lead to detachment during procedure.It may also be possible that if the device was stuck at anytime and excessive force was used to retrieve the sheath, the radiopaque band has the possibility to be forced off during the event.Since this is the only complaint from this part and lot, this will be treated as an isolated occurrence so no corrective action will be taken at this time.However, argon will continue to monitor for recurrence.
Event or Problem Description
The atrieve was opened to use for evar procedure.The stent graft going to use for evar was endurant by medtronic.A 7f/100cmguiding catheter parent from medikit was inserted to the patient from brachial artery.To pull though, the atrieve delivery catheter was inserted to the parent guiding catheter and placed in the target area.And then, the atrieve snare was inserted to the guiding catheter.At that time, the physician noticed that the radiopaque band on the tip of the delivery catheter had come off in the blood vessel.It became unable to confirm the placement of the tip of the delivery catheter without the radiopaque band, therefore, the delivery catheter and the snare was removed.After the procedure, it was confirmed the detached radiopaque band remained and stayed at th 9 inside of the patient.The patient is stable and additional treatment for the remaining radiopaque band in the patient has not been taken.
Additional Manufacturer Narrative
Udi related data quality updates only.

• 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: 17858266
• Report Number: 0001625425-2023-01209
• Device Sequence Number: 5704908
• Product Code: MMX
• UDI-Device Identifier: 20886333004007
• UDI-Public: (01)20886333004007(17)261223(10)11400479
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2024

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: 382006020
• Device Lot Number: 11400479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 08/31/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/09/2023; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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
• Patient Sex: Unknown