MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES STEALTH® CLAMPS; CLAMP, VASCULAR

Model Number	A3220
Medical Device Problem Codes	Device Slipped (1584); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: cardio thoracic procedure.Event description: it was reported by the consultant surgeon that the clamp was slipping of the aorta during the case.Case completed with another clamp.Case completed and no injury or illness occur associated with the complaint event.Intervention: case completed with another clamp.Patient status: case completed.
Additional Manufacturer Narrative
The event unit is not anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation, and the lot number was not provided.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.
Event or Problem Description
Procedure performed: cardio thoracic procedure.Event description: it was reported by the consultant surgeon that the clamp was slipping of the aorta during the case.Case completed with another clamp.Case completed and no injury or illness occur associated with the complaint event.Intervention: case completed with another clamp.Patient status: case completed.

• Brand Name: STEALTH® CLAMPS
• Common Device Name: CLAMP, 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: 22681317
• Report Number: 2027111-2025-00665
• Device Sequence Number: 9048105
• Product Code: DXC
• UDI-Device Identifier: 00607915114237
• UDI-Public: (01)00607915114237
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K950492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: A3220
• Device Catalogue Number: 100606801
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown