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); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

H6: medical device problem code 2017 clarifier- failure to follow steps/instructions.The device was not returned for analysis.A review of the manufacturing records identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Reportedly, femoral imaging was not performed.It should be noted that the electronic perclose prostyle instructions for use (ifu), states: perform a femoral angiogram to verify the location of the puncture site.In this case, it is unknown if the reported ifu violation contributed to the reported difficulties.The reported difficulty and subsequent treatment appear to be related to an interaction of the device with patient anatomy or inability to maintain position/stability of the device during deployment due to 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.

Event Description

It was reported that this was a venotomy closure of a right common femoral vein using a prostyle device after an interventional cardiac ablation procedure with an 8f sheath.Reportedly, femoral imaging was not performed.A cuff miss [suture retrieval issue] occurred.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.

• 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: 18992273
• MDR Text Key: 338809573
• Report Number: 2024168-2024-03828
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 08717648235184
• UDI-Public: (01)08717648235184(17)251130(10)3120241
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12773-03
• Device Lot Number: 3120241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2023
• 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