BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 8805400 · Received July 18, 2019

    Report

    Report Number
    2024168-2019-10168
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 27, 2019
    Report Date
    August 14, 2019
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE OTHER ADDITIONAL PROGLIDE REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.NA

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. 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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. ADDITIONALLY, THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE PROGLIDE INSTRUCTIONS FOR USE (IFU), AS A POTENTIAL ADVERSE EVENT. A CONCLUSIVE CAUSE FOR THE REPORTED BACK WALL STITCH COULD NOT BE DETERMINED. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS COMPLETED USING TWO PROGLIDE DEVICES WITH A 7F SHEATH AFTER AN AORTIC STENTING INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER HEMOSTASIS WAS ACHIEVED, THERE WAS NO PULSE IN THE LEFT LEG. AN ANGIOGRAM WAS PERFORMED THAT SHOWED OCCLUSION AT THE LEFT COMMON FEMORAL ARTERY. BALLOONING WAS PERFORMED TO OPEN THE ARTERY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS A 60 MINUTE CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596463 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 9051041 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SHEATH: 7F, ANGIOMAX| SHEATH: 7F, ANGIOMAX