BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 11829343 · Received May 14, 2021

    Report

    Report Number
    2024168-2021-04103
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 22, 2021
    Report Date
    July 12, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED RESISTANCE DURING ADVANCEMENT AND WITHDRAWAL COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE FOOT MOVEMENT ISSUE COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE GUIDE BREAK WAS CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. IT SHOULD BE NOTED THAT THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATES: DO NOT ADVANCE OR WITHDRAW THE PERCLOSE PROGLIDE SMC DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. IN THIS CASE THE DEVICE WITHDRAWAL AGAINST RESISTANCE WAS DETERMINED DUE TO OPERATIONAL CIRCUMSTANCE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE PROBLEM CODE- IMPROPER OR INCORRECT PROCEDURE OR METHOD- AGAINST RESISTANCE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A PERIPHERAL INTERVENTIONAL PROCEDURE. ANTEGRADE APPROACH WAS USED. REPORTEDLY, SOME RESISTANCE WAS FELT DURING ADVANCEMENT OF THE PROGLIDE DEVICE INTO THE ANATOMY. THE LEVER WAS RETURNED TO ITS ORIGINAL POSITION PRIOR TO DEVICE REMOVAL; HOWEVER, RESISTANCE WAS FELT DURING DEVICE REMOVAL. THE DEVICE WAS PULLED AND BROKE AT THE GUIDE, IT WAS STILL HELD TOGETHER IN ONE PIECE. THE FOOT SEGMENT WAS STUCK ON TISSUE. SURGEON WAS CALLED AND A CUT DOWN, SKIN TRACT INCISION AND FACHIA DISSECTION, WAS PERFORMED IN ORDER TO RETRIEVE THE DEVICE. GENERAL ANESTHESIA WAS GIVEN TO THE PATIENT FOR THE SURGICAL PROCEDURE. THE PROGLIDE DEVICE WAS REMOVED FROM THE ANATOMY AS A SINGLE UNIT. NO DAMAGE TO THE ARTERY WAS NOTED. PULSES WERE PRESENT AND THE ARTERY SEEMED WELL PERFUSED. HEMOSTASIS WAS ACHIEVED VIA SURGICAL SUTURING. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725638 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 1030443 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 6F SHEATH| HEPARIN