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

Catalog Number 12773-02

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported this was a closure using the pre-close technique prior to an unspecified procedure.Reportedly, the footplate on three prostyle devices did not close.Force had to be used to remove all prostyle devices.The method used to achieve hemostasis was not provided.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure or therapy.Additional information was received stating: device inserted per the instructions for use.On attempting to remove the device after deployment (after step 4 to close the footplate) the device felt stuck in the artery.Had to pull more forcefully than usual.The footplate was examined externally and seen to be not fully retracted.A total of 3 devices were used in this patient and the same issue happened with all of them.There was significant effect to patient as procedure was performed under local anesthetic.Marked pain when retrieving devices and very poor hemostasis at the end, requiring prolonged manual pressure and delay.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017- improper or incorrect procedure or method clarifier excessive force was added to capture pulling more forcefully than usual to remove the devices.The additional perclose prostyle devices referenced in b5 are filed under separate medwatch report numbers.

• 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: 18955551
• MDR Text Key: 338302238
• Report Number: 2024168-2024-03614
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12773-02
• Device Lot Number: 4010341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2024
• 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