MAUDE Adverse Event Report: ABBOTT VASCULAR PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Catalog Number 12673-05

Device Problems Failure to Cycle (1142); Unintended System Motion (1430); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983)

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

Event Date 01/16/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported this was an arteriotomy closure of the left common femoral artery using the pre-close technique via a 6f sheath hole prior to a correction of iliac pseudo aneurysm with endoprosthesis extension interventional procedure.Reportedly, a click was not heard when deploying the needle plunger of the proglide device and "it did not stay in position".The plunger was pressed to its limit and did not make the usual click.When relieving pressure on the plunger, it spontaneously returned almost 1 cm.The plunger was pushed three more times and not once did it click and it continued to return spontaneously the same distance.When the plunger was removed, a cuff miss [suture retrieval issue] was noticed.The sutures of two new proglide devices were successfully pre-placed.The sheath was upsized to a 14f sheath and the interventional procedure was completed.Hemostasis was achieved with the pre-placed proglide sutures.There was a 15-minute delay to replace the device; however, there was no reported adverse patient sequela.No additional information was provided.

Manufacturer Narrative

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.Additionally, a review of the complaint history identified no indication of a lot specific product quality issue.Femoral imaging was not performed.It should be noted that the electronic perclose proglide instructions for use (ifu), states: perform a femoral angiogram to verify the location of the puncture site.The ifu deviation did not contribute to the reported difficulties as calcification was not found and successful access was achieved.The cause of the reported difficulties cannot be determined.The subsequent treatments are due to the circumstances of the procedure.In this case, it is possible that needle to cuff miss occurred jamming the needle likely against the foot thus prohibiting the full compression of the plunger.In this condition, the needles of the device would be in a bend inducing the spring back (unintended motion) observed.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 PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) 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: 18691452
• MDR Text Key: 335185644
• Report Number: 2024168-2024-01726
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12673-05
• Device Lot Number: 2062741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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: 50 YR
• Patient Sex: Female