BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 18103470 · Received November 9, 2023

    Report

    Report Number
    2024168-2023-12476
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    October 18, 2023
    Report Date
    February 9, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    28717648013083
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED GUIDE DETACHMENT WAS CONFIRMED. THE REPORTED ENTRAPMENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; 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. D4 - LOT NUMBER UPDATED FROM LOT 2112341 TO 2102441. D4 - EXPIRATION DATE AND H4- MANUFACTURING DATE UPDATED AS A RESULT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    SUBSEQUENTLY TO THE INITIALLY FILED EMDR, ADDITIONAL INFORMATION WAS RECEIVED: EVALUATION OF THE RETURNED PROGLIDE DEVICE FOUND A GUIDE SEPARATION. FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT THE SEPARATION OCCURRED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE USING THE PRE-CLOSE TECHNIQUE. REPORTEDLY, WHEN ATTEMPTING TO PLACE THE DEVICE, IT GOT STUCK AND REQUIRED A CUT DOWN. THE USE OF PROGLIDE DEVICES AND THE PRE-CLOSE TECHNIQUE WERE ABANDONED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91810 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2102441 28717648013083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention