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

Model Number	14679-05
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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 similar incidents from this lot.In the absence of device returned for analysis, a conclusive cause for the reported difficulty could not be determined.Factors that contribute to mechanical jam with the vessel locator wings may include, but are not limited to, the vessel locator not placed against the surface of vessel during plunger deployment; flex-guide not held in alignment with body of device and the angle of tissue tract prior to and during depression.The subsequent treatment appears 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.
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 right tibial balloon catheter interventional procedure using a 6f sheath.Reportedly, when the plunger was pushed, the vessel locator wings did not open.There was no resistance pushing the plunger.The device was removed and 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.

• 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: 17192152
• Report Number: 2024168-2023-06677
• Device Sequence Number: 7333514
• Product Code: MGB
• UDI-Device Identifier: 08717648175060
• UDI-Public: 08717648175060
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 06/23/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown