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

Catalog Number	14679-05
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Pseudoaneurysm (2605); Swelling/ Edema (4577)
Date of Event	03/16/2024
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 after a diagnostic cerebral angiogram procedure with a 5f sheath.Reportedly, the starclose was deployed and did not achieve hemostasis.The patient experienced pain and swelling in the groin.A pseudoaneurysm was observed.Manual compression was applied and achieved hemostasis.The pseudoaneurysm resolved.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported failure to achieve hemostasis; however, the unexpected medical intervention appears to be related to circumstances of the procedure.The patient effects are known inherent risk of the procedure.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: 19047221
• Report Number: 2024168-2024-04299
• Device Sequence Number: 8483263
• Product Code: MGB
• UDI-Device Identifier: 08717648175060
• UDI-Public: (01)08717648175060(17)250601(10)3110141
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/22/2024

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: 06/01/2025
• Device Catalogue Number: 14679-05
• Device Lot Number: 3110141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: 62 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG