MAUDE Adverse Event Report: ABBOTT VASCULAR STARCLOSE SE VASCULAR CLOSURE SYSTEM; VESSEL CLOSURE CLIP

Model Number	14679-05
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
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 right common femoral artery using a starclose se device after a coiling aneurysm embolization procedure using a 6f sheath.Reportedly, the clip deployed; however, hemostasis was not fully achieved as only partial capture of the vessel was obtained with the clip.Manual compression was applied to achieve 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
The device was returned for analysis.The reported failure to fire is case conditional and cannot be replicated in a lab environment, therefore was not confirmed.A review of the manufacturing records revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.In this case, it is likely the angle of the device was inadequate to fully capture the vessel.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: STARCLOSE SE VASCULAR CLOSURE SYSTEM
• Common Device Name: VESSEL CLOSURE CLIP
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17025110
• Report Number: 2024168-2023-05639
• Device Sequence Number: 20564976
• Product Code: MGB
• UDI-Device Identifier: 08717648175060
• UDI-Public: 08717648175060
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2024
• Device Model Number: 14679-05
• Device Catalogue Number: 14679-05
• Device Lot Number: 3011741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 77 KG