BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3182610 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03862
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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. THE OTHER PERCLOSE PROGLIDE DEVICES WERE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED NEEDLE-TO-CUFF MISS WAS NOT CONFIRMED AS ANALYSIS OF THE DEVICE INDICATED THE LINK WAS PULLED OUT FROM THE SWAGE-END OF THE POSTERIOR CUFF. HOWEVER, THE EFFECTS OF THE LINK BEING PULLED OUT FROM THE SWAGE-END OF THE POSTERIOR CUFF CAN APPEAR SIMILAR TO THE OPERATOR AS THE REPORTED EXPERIENCE. BASED ON 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED OF THE RIGHT COMMON FEMORAL ARTERY USING THREE PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING DEPLOYMENT OF THE THREE PROGLIDE DEVICES THROUGH A 7-FRENCH SIZED ACCESS SITE, ANTERIOR NEEDLE-TO-CUFF MISSES OCCURRED. WHEN THE NEEDLE PLUNGERS WERE REMOVED, NO LINK OR SUTURE WAS ATTACHED TO THE NEEDLE. THE SUTURES OF ADDITIONAL PROGLIDE DEVICES WERE DEPLOYED AND SET TO THE SIDE. THE ACCESS SITE WAS DILATED TO AN UNSPECIFIED SIZE. AFTER CONCLUSION OF THE TAVI PROCEDURE, THE KNOTS FROM THE ADDITIONAL PRE-PLACED PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284124 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30415K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7-FRENCH, HEPARIN