BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 9882512 · Received March 26, 2020

    Report

    Report Number
    2024168-2020-02926
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    February 1, 2020
    Report Date
    July 22, 2020
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATED MEDWATCH REPORT NUMBERS. ATTACHMENT: USER FACILITY MEDWATCH # (B)(4). B3: ESTIMATED DATE REVISED BASED ON ATTACHED USER FACILITY MEDWATCH.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED VIA USER FACILITY MEDWATCH REPORT# (B)(4): INTERVENTIONAL RADIOLOGY TEAM MEMBERS REPORTED ON RECENT CASES OF THE PERCLOSE PROGLIDES NOT WORKING. THEY REPORTED IT HAS BEEN WITH MORE THAN ONE PROVIDER, THAT THIS HAS BEEN GOING ON FOR A COUPLE OF MONTHS, BUT THEY NEGLECTED TO WRITE UP EACH EVENT OF PROGLIDE FAILURE. THE ACTUAL INVOLVED DEVICES WERE NOT SAVED. NO PATIENTS WERE INJURED, BUT ADDITIONAL PROGLIDES WERE NECESSARY TO CLOSE THE ARTERIOTOMIES RESULTING IN ADDITIONAL COSTS. LOT NUMBERS WITH FAILURES ARE: REF# 12673-03/ LOT#9081244 - WE HAD 5 OF ONE BOX FAIL. TWO REMAINING WERE REMOVED FROM USE. LOT# 9112241, WE HAD 3 FAIL FOR DR. 1. REMOVED REMAINING ONE FROM SHELF. LOT# 9121941 - 1 FAILED FOR DR. 2. HE SAID NO CALCIUM OR OTHER REASON IT SHOULD HAVE FAILED. THE 2ND PROGLIDE DID WORK. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A REVIEW OF THE COMPLAINT HISTORY WAS NOT PERFORMED AS A SIMILARITY COULD NOT BE DETERMINED. WITHOUT THE DEVICE RETURNED FOR ANALYSIS AND SPECIFIED FAILURE MODE A CONCLUSIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED A PROGLIDE DEVICE FAILED IN THE PATIENT. THE METHOD IN WHICH HEMOSTASIS WAS ACHIEVED WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED. ESTIMATED DATE OF PROCEDURE (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345254 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 9121941 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention