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

Model Number	14679-01
Medical Device Problem Codes	Failure to Cut (2587); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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 an arteriotomy closure of the left common femoral artery using a small-bore sheath with a starclose device after a bilateral iliac stenting procedure.Reportedly, the thumb advancer could not be fully advanced.The sheath became shredded, and it was noted that the garage leaves were bent.Manual compression was held for 30 minutes to achieve hemostasis.Although a delay was reported due to the need for manual compression, there was no significant impact to the patient due to the delay.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported difficulty splitting the sheath was confirmed based on the returned device condition.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 sheath indicates there was device angle changed during thumb advancer/slider stroke such that garage leaves interacted with sheath and contributed to the reported difficulty splitting the sheath (failure to split the sheath).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: 22828563
• Report Number: 2024168-2025-08600
• Device Sequence Number: 4577660
• Product Code: MGB
• UDI-Device Identifier: 08717648079467
• UDI-Public: (01)08717648079467(17)261101(10)5041541
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/28/2025

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: 5041541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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 Age: 71 YR
• Patient Sex: Male