BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4110131 · Received September 23, 2014

    Report

    Report Number
    2024168-2014-06115
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE BREAK WAS CONFIRMED. TWO OF THE ANTERIOR CUFF TABS (MEASURING APPROXIMATELY 0.01 BY 0.01 INCHES) WERE BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT WAS REPORTED THAT THE PROGLIDE DEVICE WAS USED IN A CALCIFIED VESSEL. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, VIA A 8F SHEATH PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE SUTURE OF THE FIRST PROGLIDE DEVICE WAS SUCCESSFULLY PLACED. REPORTEDLY, A SUTURE BREAK OCCURRED WITH THE SECOND PROGLIDE DEVICE. ANOTHER PROGLIDE DEVICE WAS USED FOR SUCCESSFUL SUTURE PLACEMENT USING THE PRECLOSE TECHNIQUE. THE EVAR PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED WITH THE SUCCESSFULLY PRE-PLACED SUTURES OF THE FIRST AND THIRD PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE AND IN THE LARGE HOLE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590768 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40623K1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SHEATH: 8F, HEPARIN