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

Catalog Number 12773-03

Device Problems Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Malposition of Device (2616)

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

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that this was a closure of a very deep right common femoral vein with a prostyle device using the pre-close technique via a 6fr sheath hole prior to a left atrial appendage occlusion procedure.Reportedly, there was no bleed back from the marker lumen.It was viewed under fluoroscopy, and it was judged that the device was in the vein enough, therefore the suture was deployed and pre-placed.The sheath was upsized to 16f, and the procedure was completed.After advancing the knot to the vessel wall, bleeding continued from the access site.It was noted that the suture was deployed in soft tissue and not the vein.A figure of eight suture was applied to achieve hemostasis.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure or therapy.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 clarifier- failure to follow steps/ instructions.

• 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: 18984035
• MDR Text Key: 338658176
• Report Number: 2024168-2024-03731
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12773-03
• 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
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 129 KG