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

Model Number	14679-05
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Open or Close (2921); Mechanical Jam (2983)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was an arteriotomy closure of the right common femoral artery using a starclose device after a pulmonary arteriogram and interventional procedure using a 5f sheath.Reportedly, the clip was deployed; however, the vessel locator wings did not retract and the device could not be removed from the patient.The bailout methods were used; however, this was unsuccessful and the device still could not be removed.A vascular surgeon was called who performed cut down surgery to remove the device and achieve hemostasis.It appeared that the clip had grabbed the bottom of the arterial wall but also grabbed tissue.There was no adverse patient sequela; however, there was a reported clinically significant delay in the procedure or therapy due to the need for the cut down surgery.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection and functional testing were performed on the returned device.The reported difficulty to retract the vessel locator wings and mechanical jam of the safety release could not be tested due to the condition of the returned device.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 specific issue.Based on observations from the returned analysis and case details/response from the vascular surgeon, it is likely that the difficulty to close the vessel locator wings was due to the device becoming stuck on tissue contributing to the safety release issue resulting in the entrapment of the device.The patient effect and treatment appears to be related to the circumstances of the procedure.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: 22349899
• Report Number: 2024168-2025-06631
• Device Sequence Number: 8639078
• Product Code: MGB
• UDI-Device Identifier: 08717648175060
• UDI-Public: (01)08717648175060(17)260701(10)4110641
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2026
• Device Model Number: 14679-05
• Device Catalogue Number: 14679-05
• Device Lot Number: 4110641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown