MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES STEALTH® CLAMP INSERTS; Clamp, Vascular

Model Number	A0A13
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The even unit is not anticipated to be returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: descending thoracic aorta to bilateral femoral bypass.Event description: i am from "[hospital]" in (b)(6).One of our surgeons really likes the aortic stealth clamps, however the clamp inserts are quite slippery and have actually come off the aorta a few different times.Do you have a more 'sticky' insert that will not slide off of the aorta? he is using them correctly.Are other hospitals reporting this problem? he has unfortunately, stopped using them as he cannot risk them sliding during the procedure.Three device malfunctions occurred during three different procedures.The same doctor experienced the issue three times.It happened a couple of times, the rubber doesn't grip the tissue the whole clamp falls off the aorta.The type of insert typically used is stealth insert.There was no separation of the insert pad from the base.Additional information provided by "[name]" on 28jan2026 by email: i have the reference number for the stealth inserts, and it is a0a13.Are other facilities having these same issues? it is almost like the rubber is too slippery to grip the aorta adequately.We used a different clamp to resolve the case.Each time, it has been slipping off the aorta during the procedure.This causes blood flow and obstruction of view.The most recent was jan 13, 2026.The other 2 events i did not keep track of dates.Descending thoracic aorta to bilateral femoral bypass.No other devices used.Unsure of lot number.Model is a0a13.No, the product is not available for return.Intervention: we used a different clamp.Patient status: patient is doing well.

• Brand Name: STEALTH® CLAMP INSERTS
• 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 ; +1(949)713-5359
• MDR Report Key: 24447484
• Report Number: 2027111-2026-00397
• Device Sequence Number: 10220752
• Product Code: DXC
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K950492
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: A0A13
• Device Catalogue Number: 101370501
• Device Lot Number: 1451442
• Was Device Available for Evaluation?: No
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2022
• 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
• Patient Sex: Unknown