MAUDE Adverse Event Report: AV-TEMECULA-CT PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Catalog Number 12673-05

Device Problems Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.Investigation is not yet complete.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The other two perclose proglide devices, referenced are filed under separate medwatch manufacturer report reference numbers.

Event Description

It was reported that suture placement in the right common femoral artery was attempted with a proglide device using the pre-close technique via a 12f sheath.Reportedly, the proglide suture came out with the plunger.The sutures of two new proglide devices were successfully pre-placed.The stent-graft procedure was completed.The pre-placed sutures were tightened; however, hemostasis was not completed successfully.Manual arterial compression 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.

Manufacturer Narrative

(b)(4).Subsequent to the initial medwatch report, the following additional information was received: the two pre-placed proglide sutures could achieve hemostasis.No issue was found with the two additional proglide devices.A risk assessment review was not conducted as there was no device malfunction or adverse patient effect.However, because the initial medwatch report has already been filed, this event must remain reportable.No investigation required.

Event Description

Subsequent to the initial medwatch report the following additional information was received.Reportedly, the two pre-placed proglide sutures were successfully placed and could achieve hemostasis.No device issue was being reported with the two additional proglide devices.No additional information was provided.

• Brand Name: PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
• Type of Device: SUTURE MEDIATED CLOSURE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7654932
• MDR Text Key: 112878997
• Report Number: 2024168-2018-05117
• Device Sequence Number: 1
• Product Code: MGB
• 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: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12673-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SHEATH: 12F
• Patient Outcome(s): Required Intervention