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

Model Number	14679-05
Medical Device Problem Codes	Off-Label Use (1494); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was an arteriotomy closure of a calcified left common femoral artery using a starclose device after an interventional atherectomy and percutaneous transluminal angioplasty procedure with a 5f sheath.Reportedly, the thumb advancer was unable to advance as resistance was felt.The sheath was partially split, and the garage tube was flared out.The sheath was then manually split to deploy the clip.Bleeding was observed after deployment and manual compression was used to achieved hemostasis.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
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6 medical device problem code: 1494 - patient selection.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported failure to split 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.It was reported that this was an arteriotomy closure of a calcified right common femoral artery using a starclose device with a small-bore sheath.It should be noted that the starclose instructions for use (ifu), states: do not deploy the clip in areas of calcified plaque.It is unknown if the patient calcification contributed to the reported difficulty splitting the sheath.Based on the reported information and the observations from the returned device analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.It is unknown if the instructions for use (ifu) deviation contributed to the reported event.The observed evidence of damage to the flex-guide (carving), garage leaves and sheath damage indicates there was device angle change during thumb advancer/slider stroke such that garage leaves interacted with flex-guide and sheath and contributed to the reported difficulty splitting the sheath (failure to split the sheath).The subsequent treatment appears to be related to 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: 22010559
• Report Number: 2024168-2025-04972
• Device Sequence Number: 17478522
• Product Code: MGB
• UDI-Device Identifier: 08717648175060
• UDI-Public: (01)08717648175060(17)260301(10)4070341
• 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): 06/10/2025

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: 03/01/2026
• Device Model Number: 14679-05
• Device Catalogue Number: 14679-05
• Device Lot Number: 4070341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American