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

Model Number	14679-01
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Jam (2983); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that this was arteriotomy closure of the right common femoral artery was attempted using a starclose device after a cerebral angiogram diagnostic procedure using a 6f sheath.Step one through three were performed as intended.Reportedly, the clip did not deploy at step four, and the safety release did not work, and the device was stuck in the anatomy.A cut-down was then performed to remove the device and clip.Hemostasis was achieved via cut-down and surgical suturing.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported firing problem and mechanical jam with the safety release mechanism was not confirmed as the device functioned as intended.The reported device entrapment could not be confirmed as the exact conditions encountered by the device during the procedure could not be replicated in the test environment.Sterile unused starclose se vascular closure system devices from part# 14679-01 and lot# 5071441 were returned.Testing was performed and verified the device properly deployed the clip and both the safety release mechanism and access ports functioned as expected.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 the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.The observed evidence of damage to the flex-guide (carving), sheath and garage leaves indicates there was device angle changed during thumb advancer/slider stroke deployment thus contributing to the reported torn sheath.Because of these interactions, it is possible the trigger button was not depressed to deploy the clip and the safety release mechanism was attempted to be used but was not properly depressed to release the plunger and vessel locator wings for device removal.Based on the returned device condition, the reported device entrapment appears to be related to interaction with patient tissue as the device was returned with the plunger and vessel locator wings in the deployed position.The reported subsequent treatment appears to be related to procedure circumstance.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: 23240389
• Report Number: 2024168-2025-10991
• Device Sequence Number: 15607190
• Product Code: MGB
• UDI-Device Identifier: 08717648079467
• UDI-Public: (01)08717648079467(17)261201(10)5071441
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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 Model Number: 14679-01
• Device Catalogue Number: 14679-01
• Device Lot Number: 5071441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male