BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 17056130 · Received June 2, 2023

    Report

    Report Number
    2024168-2023-05836
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 21, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648113154
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE FAILURE TO CYCLE COULD NOT BE CONFIRMED AS THE COMPONENTS NEEDED WERE NOT RETURNED. THE ANALYSIS IDENTIFIED A POSTERIOR FOOT BREAK WHICH WAS NOT RETURNED. THE PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY AND THE SUBSEQUENT TREATMENT IS RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, IT¿S LIKELY AN INTERACTION WITH ANATOMY CAUSED A NEEDLE DEFLECTION CREATING FAILURE TO CYCLE AND POSSIBLY A STRIKE TO THE FOOT CAUSING SEPARATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. D9 CORRECTION: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM NO TO YES. H6 CORRECTION: COMPONENT CODES 788, 3036 ADDED. H6 CORRECTION: TYPE OF INVESTIGATION CODES 10, 4116 ADDED. H11 CORRECTION: SUBSEQUENT TO FILING THE PREVIOUS REPORT, IT WAS DETERMINED THAT THE COMPLAINT DEVICE RECEIVED AND CAPTURED UNDER CN-170532, PREVIOUSLY FILED UNDER MANUFACTURER REPORT #2024168-2023-05835-01, WAS ACTUALLY THE COMPLAINT DEVICE FOR THIS COMPLAINT. THEREFORE, THE MFG NARRATIVE HAS BEEN UPDATED TO INCLUDE THE DEVICE ANALYSIS.

    Additional Manufacturer Narrative · 0

    D9: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO AS THE DEVICE WAS NOT RETURNED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. LOT HISTORY RECORD AND CORRECTIVE AND PREVENTIVE ACTION 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.

    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 DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, THE FIRST PROGLIDE FOOTPLATE WOULD NOT COMPLETELY OPEN TO CATCH THE VESSEL WALL. A SECOND PROGLIDE HAD NO SUTURE COMING OUT WITH PLUNGER REMOVAL. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO 18F AND THE AAA PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. RETURNED DEVICE ANALYSIS FOUND ONE PROGLIDE DEVICE HAS A POSTERIOR FOOT BREAK. THE FOOT WAS NOT RETURNED WITH THE DEVICE. THE LOCATION OF THE DETACHED FOOT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, THE FIRST PROGLIDE FOOTPLATE WOULD NOT COMPLETELY OPEN TO CATCH THE VESSEL WALL. THERE WAS NO SUTURE WITH PLUNGER REMOVAL FOR A SECOND PROGLIDE. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO 18F AND THE AAA PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES. THERE WAS NO 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
    218986 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2083042 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention