MAUDE Adverse Event Report: ABBOTT VASCULAR PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM; SUTURE MEDIATED CLOSURE

Catalog Number 12773-03

Device Problems Failure to Cycle (1142); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/12/2023

Event Type  Injury  

Event Description

It was reported that an arteriotomy closure of the right common femoral artery was attempted using a prostyle device after a coronary interventional procedure with a 6f sheath.Reportedly when the plunger was removed, there was no suture present.Then, after closing the lever, the device would not come out of the patient.Force was applied to remove the device.Once removed, the lever was opened and a separated portion of the footplate fell out of place.A new prostyle device 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.

Manufacturer Narrative

H6: medical device problem code 2017, clarifier - excessive force.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

Analysis was performed on the device.The reported needle to cuff miss was confirmed.The reported foot separation was confirmed.The reported difficult to remove 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 revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.Reportedly, force was used to remove the device.The instructions for use (ifu) states: do not advance or withdraw the perclose prostyle device against resistance until the cause of that resistance has been determined.Excessive force used to advance or torque the perclose prostyle device should be avoided, as this may lead to significant vessel damage and/or breakage of the device, which may necessitate intervention and/or surgical removal of the device and vessel repair.In this case, it is unknown if the reported ifu violation contributed to the reported difficulties.The reported difficulties and subsequent treatment appear to be related to the circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
• Type of Device: SUTURE MEDIATED CLOSURE
• 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: 18471881
• MDR Text Key: 332373073
• Report Number: 2024168-2024-00391
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960043
• 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,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12773-03
• Device Lot Number: 3100541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2023
• 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
• Patient Outcome(s): Required Intervention