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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM Back to Search Results
Catalog Number 12673-05
Device Problems Failure to Cycle (1142); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2020
Event Type  Injury  
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. It should be noted that the perclose proglide instructions for use (ifu), states: for sheath sizes greater than 8f, at least two devices and the pre-close technique are required. 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.

 
Event Description

It was reported that an arteriotomy closure of the left common femoral artery was attempted using a proglide device with a 8. 5f sheath after a percutaneous coronary interventional procedure. Reportedly, when plunger of the proglide device was pushed and removed, the suture was not present. A new proglide device was used 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.

 
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Brand NamePERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Type of DeviceSUTURE 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 Key10475039
MDR Text Key205083653
Report Number2024168-2020-07254
Device Sequence Number1
Product Code MGB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberP960043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number12673-05
Device LOT Number9092442
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/24/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/31/2020 Patient Sequence Number: 1
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