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

Catalog Number 14679-01

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

H6: medical device problem code 2017 ¿ failure to follow steps/instructions h6: medical device problem code 2017 ¿ against resistance manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that this was an arteriotomy closure of the right common femoral artery using a starclose se after a superficial femoral artery intervention with a 6f sheath.Reportedly, all steps were performed and the clip achieved hemostasis; however, there was resistance removing the device.No safety mechanisms were used to remove the device and no damage to the vessel was noted.Manual compression was added as a precautionary measure.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
• Type of Device: 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: 18998851
• MDR Text Key: 338879888
• Report Number: 2024168-2024-03770
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 08717648079467
• UDI-Public: (01)08717648079467(17)250701(10)3081841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14679-01
• Device Lot Number: 3081841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1