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

Catalog Number	12673-05
Medical Device Problem Codes	Failure to Cycle (1142); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported this was an arteriotomy closure of the right common femoral artery using the pre-close technique via a 6f sheath hole prior to a micra (leadless pacemaker) implantation interventional procedure.Reportedly, at step 2 the device was stabilized at an angle below 45 degrees and a cuff miss [suture retrieval issue] occurred with the proglide device.The sutures of two new proglide devices were successfully pre-placed.The sheath was upsized to a 23f sheath and the micra (leadless pacemaker) procedure was completed.Hemostasis was achieved with the pre-placed proglide sutures.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Reportedly, the device was stabilized at an angle below 45 degrees.It should be noted that the perclose proglide instructions for use, states: position the device at a 45-degree angle.Deploy the foot by lifting the lever (marked #1) on the top of the handle.It is unknown if the reported violation of the ifu contributed to the reported difficulties.The reported difficulties 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
• Common Device Name: 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: 12903645
• Report Number: 2024168-2021-10911
• Device Sequence Number: 4854369
• Product Code: MGB
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P960043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 12673-05
• Device Lot Number: 1030741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELIQUIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown