MAUDE Adverse Event Report: ABBOTT VASCULAR INC. STARCLOSE SE¿; DEVICE, HEMOSTASIS, VASCULAR

Model Number	14679-01
Medical Device Problem Codes	Break (1069); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was an arteriotomy closure of the right common femoral artery using a starclose se device after a hemorrhoidal artery embolization procedure.Reportedly, the trigger button was pressed; however, the clip did not deploy.The clip was not in the patient anatomy or the device.The clip was later seen loose inside the package with the starclose se device when packaging the device after the procedure.Manual compression was applied to achieve hemostasis.There were no adverse patient effects and no reported clinically significant delay in the procedure or therapy.No additional information was provided.Analysis of the returned starclose se device revealed damage noted to the one vessel locator wing at the distal end was separated but still intact.
Additional Manufacturer Narrative
A visual inspection and functional testing was performed on the returned device.The reported failure to fire the clip could not be replicated in a testing environment as it was based on operational circumstances.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot of specific issue.Based on the information received, the investigation determined that the reported issue appears to be related to operational context.The returned device condition noted the catch was released indicating the clip was successfully deployed.The vessel locator wings were also noted to be separated indicating the clip likely interacted with and caught on the vessel locator wings during deployment.This interaction likely contributed to the vessel locator wing separating as they are retracting once the clip was fired.Once the device was removed from the anatomy and placed in the packaging tray, the clip likely released from the distal end of the device and landed on the packaging tray; therefore, contributing to the reported "clip was later seen loose inside the package".Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: STARCLOSE SE¿
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 24329058
• Report Number: 2024168-2026-00612
• Device Sequence Number: 18497730
• Product Code: MGB
• UDI-Device Identifier: 08717648079467
• UDI-Public: (01)08717648079467(17)261201(10)5072541
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P050007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 14679-01
• Device Catalogue Number: 14679-01
• Device Lot Number: 5072541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2025
• 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