BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 9882362 · Received March 26, 2020

    Report

    Report Number
    2024168-2020-02922
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. 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 OF THE DEVICE. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATED MEDWATCH REPORT NUMBERS. ATTACHMENT: USER FACILITY MEDWATCH REPORT#(B)(4). B3 DATE OF EVENT ESTIMATION WAS UPDATED FROM (B)(6) 2020 TO (B)(6) 2020.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: USER FACILITY MEDWATCH REPORT#(B)(4) WAS RECEIVED AND STATES: 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 WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL 4 PROGLIDES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED FIVE PROGLIDE DEVICES WERE USED IN A PATIENT. REPORTEDLY, A "CUFF MISS" WAS LIKELY THE CAUSE OF THE DEVICE MALFUNCTION. THE METHOD OF HOW HEMOSTASIS WAS ACHIEVED WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346221 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 9081244 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention