BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 19487827 · Received June 7, 2024

    Report

    Report Number
    2024168-2024-06712
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    May 9, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. 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. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D1 CORRECTION: BRAND NAME UPDATED. D2A CORRECTION: COMMON DEVICE NAME UPDATED. D3 CORRECTION: NAME, ADDRESS UPDATED. D4 CORRECTION: LOT NUMBER UPDATED FROM 4021141 TO 4032041. E1 CORRECTION: FIRST, LAST NAME UPDATED FROM JILL TAVARES TO AMIN AL-AHMAD. E1 CORRECTION: TITLE UPDATED FROM MS. TO DR. E3 CORRECTION: OCCUPATION UPDATED FROM OTHER HEATH CARE PROFESSIONAL TO PHYSICIAN. H6 CORRECTION: MEDICAL DEVICE PROBLEM CODE 2610 UPDATED TO 1142.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF THE RIGHT FEMORAL VEIN USING THREE PROGLIDE DEVICES RELATIVE TO AN ABLATION PROCEDURE. REPORTEDLY, DEPLOYMENT FAILURE OCCURRED WITH ALL THREE PROGLIDE DEVICES. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENTLY TO THE INITIALLY FILED MDRS, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING THE PRE-CLOSE TECHNIQUE VIA AN 8.5F SHEATH HOLE PRIOR TO AN ELECTROPHYSIOLOGY ABLATION INTERVENTIONAL PROCEDURE USING THE THREE PROGLIDE DEVICES. REPORTEDLY, NO SUTURE WAS PRESENT WHEN THE PLUNGER WAS RETRACTED. THIS OCCURRED WITH ALL THREE DEVICES. THE USE OF PROGLIDE DEVICES AND THE PRE-CLOSE TECHNIQUE WERE ABANDONED. THE USE OF AN 8.5 SHEATH WAS CONTINUED AND THE ELECTROPHYSIOLOGY ABLATION PROCEDURE WAS COMPLETED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107125 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 4032041 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention