MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ATRIEVE VASCULAR SNARE KIT 7FR

Model Number	382007030
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be submitted upon investigation completion.
Event or Problem Description
The atrieve was used at afx procedure.An afx sheath was inserted from right fa and placed in the ta.And then the delivery catheter with the snare was inserted from the left fa and placed in the ta likewise.Right after that, blood spouted from the surface of the delivery catheter.The device was checked and noticed that there was a pinhole in the delivery catheter and blood was spouting from there.The pin hole located approx.37 cm from the distal tip of catheter.The physician determined the location of the pin hole did not affect on the procedure, therefore, he covered the pinhole with a taping and continued to use the device.The taping that was put to cover the pinhole had been removed at the hospital before returning the device to sugan.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.Evaluation summary: a review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.One used sample was returned to argon from the customer.A visual inspection was performed on the returned product.The visual inspection determined that there was a pinhole as well as two additional indentations in a uniform line on the delivery catheter sheath.Because of the uniformity, it is speculated that the observed damage may have been caused by a tool or machinery.The delivery catheter sheath is a purchased part so, it is not known if the damage happened at the supplier or during an event within the user's environment.Since a root cause cannot be confirmed, a corrective action cannot be confirmed.Argon will continue to monitor for recurrence.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 7FR
• Common Device Name: ATRIEVE VASCULAR SNARE KIT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18856950
• Report Number: 0001625425-2024-00948
• Device Sequence Number: 8282907
• Product Code: MMX
• UDI-Device Identifier: 20886333003994
• UDI-Public: (01)20886333003994(17)280926(10)11500791
• 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,Distributor
• 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: 382007030
• Device Lot Number: 11500791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 05/31/2024; 08/31/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/30/2024; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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
• Patient Sex: Unknown