BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 9882619 · Received March 26, 2020

    Report

    Report Number
    2024168-2020-02929
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    February 1, 2020
    Report Date
    July 23, 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

    (B)(4).

    Additional Manufacturer Narrative · 0

    METHOD CODE ADDED.

    Additional Manufacturer Narrative · 0

    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. SIMILAR INCIDENT REVIEW COULD NOT BE COMPLETED AS SIMILARITY COULD NOT BE DETERMINED AS A SPECIFIC FAILURE MODE WAS NOT PROVIDED. IN THE ABSENCE OF DEVICE RETURNED FOR ANALYSIS OR A SPECIFIC FAILURE MODE REPORTED, A CONCLUSIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. A STERILE DEVICE FROM THE ACCOUNT WITH THE SAME PART/ LOT NUMBER AS THE ORIGINAL COMPLAINT DEVICES WAS RETURNED AND TESTED. THE DEVICE SUCCESSFULLY DEPLOYED WITH NO ISSUE NOTED THUS INDICATING THE DEVICE FUNCTIONED AS EXPECTED. THE ADDITIONAL PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED 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# (B)(4)/ 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

    DATE OF EVENT: ESTIMATED DATE. THE CUSTOMER REPORTED THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL TWO PROGLIDE DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THREE DEVICES FAILED IN THE PATIENT. THE METHOD IN WHICH HEMOSTASIS WAS ACHIEVED WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345545 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 9112241 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention