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

Model Number	14679-01
Medical Device Problem Codes	Off-Label Use (1494); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was an arteriotomy closure of the mildly calcified right common femoral artery using a starclose se device after a left superficial femoral artery interventional procedure using a 6f sheath.Scar tissue was present at the access site.Reportedly, resistance was met during thumb advancement in step 3 and at the same time the whole starclose device popped out of the vessel; however, the vessel locator wings remained opened with the plunger was still engaged.Manual compression was applied to achieve hemostasis.There was no adverse patient effects and no reported clinically significant delay in the procedure or therapy.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.Based on the information provided, a definitive cause for the reported issue could not be determined.Factors that may contribute to the resistance with the thumb advancer include, but are not limited to, inadequate nick and spread, device angle change prior to thumb advancer stroke completion or vessel locator not placed against the surface of the vessel.Reportedly, the device was used in a calcified artery.It should be noted the starclose instruction for use states: do not deploy the clip in areas of calcified plaque.In this case, calcification is not a known contributor to mechanical jam with the thumb advancer.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.H6 medical device problem code: 1494 - patient selection.

• 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: 23607651
• Report Number: 2024168-2025-11667
• Device Sequence Number: 15754137
• Product Code: MGB
• UDI-Device Identifier: 08717648079467
• UDI-Public: (01)08717648079467(17)261201(10)5072541
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 11/20/2025

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?: 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/20/2025
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White