MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES SOFT / FIBRA® CLAMP INSERT; CLAMP, VASCULAR

Model Number	G-8650
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluations.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: aortic valve replacement event description: it was identified during aortic blockade.There was no clinical impact to the patient.While the insert was being used for aortic blockade, it was identified that the rubber part of the product detached from the product by the surgeon.The detachment did not affect the blockade, and the procedure was successfully completed with the continuous use of the insert.The product in question will be returned to you for your investigation.Additional information provided on 25feb2026: one unit malfunctioned.The detachment was only partial.So, the insert didn't fall off.Intervention: the device was used continuously.Patient status: this event didn't affect the procedure, which means the patient wasn't affected.

• Brand Name: SOFT / FIBRA® CLAMP INSERT
• 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: 24729894
• Report Number: 2027111-2026-00465
• Device Sequence Number: 18704375
• Product Code: DXC
• UDI-Device Identifier: 00607915111281
• UDI-Public: (01)00607915111281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K883790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: G-8650
• Device Catalogue Number: 100063401
• Device Lot Number: 1477991
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 01/23/2023
• 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