MAUDE Adverse Event Report: ABBOTT VASCULAR INC. StarClose SE¿; Device, Hemostasis, Vascular

Model Number	14679-01
Medical Device Problem Codes	Noise, Audible (3273); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was an arteriotomy closure using a starclose device after a procedure.Reportedly, after deploying the clip, the flex guide or delivery tube snapped "[audible noise]", forcing the physician to pull the clip out of artery "[clip stuck on distal end of sheath or device when device was withdrawn]".Manual compression was used to achieve hemostasis.There were no reported adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 provided, a definitive cause for the reported issue could not be determined.Factors that contribute to firing problem and audible sound of the device may include, but are not limited to, inadequate nick and spread, user presses the firing button (#4) prior to full advancement of the thumb advancer, user pulls back on device during clip deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B3 - estimated date.

• Brand Name: StarClose SE¿
• Common Device Name: Device, Hemostasis, Vascular
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• 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--462 ; +1(951)914-5259
• MDR Report Key: 50917956
• Report Number: 2024168-2026-03727
• Device Sequence Number: 17593518
• Product Code: MGB
• UDI-Device Identifier: 08717648079467
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 5121941
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2025
• 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