MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES STEALTH® SPRING CLIP; CLIP, VASCULAR

Model Number	A1604
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.
Event or Problem Description
Type of procedure: [av fistula].Event description: [during the av fistula creation, [doctor] applied the soft/soft clip, to the brachial artery for occlusion.However, it slipped off due to insufficient traction of the pad surface to the artery per his feedback.The vessel was not damaged.Patient is fine.[doctor] liked the latis/latis and fibra options he used.] patient status: [patient is fine].Intervention: [usage of a clip with a different pad, such as soft/fibra.].
Event or Problem Description
Procedure performed: av fistula.Event description: feedback submission - complaint notification -(b)(4).During the av fistula creation, [doctor] applied the soft/soft clip (3/4 force) a1604, lot: 1507291, to the brachial artery for occlusion.However, it slipped off due to insufficient traction of the pad surface to the artery per his feedback.The vessel was not damaged.Patient is fine.[doctor] liked the latis/latis and fibra options he used.Patient status: patient is fine.Intervention: usage of a clip with a different pad, such as soft/fibra.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.

• Brand Name: STEALTH® SPRING CLIP
• Common Device Name: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 22020204
• Report Number: 2027111-2025-00525
• Device Sequence Number: 9390896
• Product Code: DSS
• UDI-Device Identifier: 00607915113902
• UDI-Public: (01)00607915113902
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K883909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: A1604
• Device Catalogue Number: 101374201
• Device Lot Number: 1507291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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