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

Model Number	14679-05
Medical Device Problem Codes	Noise, Audible (3273); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
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 an arteriotomy closure of the left common femoral artery was attempted using a starclose device after a diagnostic procedure with a 6f sheath.Reportedly, the clip deployed, but after a 2 minute groin hold, there was continued bleeding.The physician noted an audible "thug" sound and not the usual distinct/crisp sound expected when deploying starclose.The clip remained in the patient.Manual arterial compression was used 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
Analysis was performed on the returned device.The reported failure to achieve hemostasis or the reported noise (the physician noted an audible "thug" sound) could not be confirmed as the exact conditions encountered by the device during the procedure could not be replicated in the test environment.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the returned device condition, a conclusive cause for the reported difficulties cannot be determined.Factors that contribute failure to achieve hemostasis may include, but not limited to, user pulls back on the device during clip deployment, user rocks/twists the device during device withdraw, clip interacts with the vessel locator wings.It is possible that interaction with the clip during device removal post deployment contributed to the reported "thug" sound.The subsequent treatments appear to be related to procedure circumstance.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design 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: 17032212
• Report Number: 2024168-2023-05681
• Device Sequence Number: 17740750
• 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): 07/10/2023

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: 09/12/2024
• Device Model Number: 14679-05
• Device Catalogue Number: 14679-05
• Device Lot Number: 2111641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 25 KG