BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3112541 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03048
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY THE SUTURE FROM THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SUTURE PULLING OUT FROM THE VESSEL WAS CONFIRMED. BASED ON VISUAL INSPECTION OF THE RETURNED SUTURE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. REPORTEDLY THE COMMON FEMORAL ARTERY WAS MILDLY CALCIFIED. THE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE, REFERENCED IS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE (EVAR), PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED OF A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY THROUGH A 6-FRENCH SIZED ACCESS SITE. THE SUTURE OF THE FIRST DEVICE WAS DEPLOYED LATERALLY AND SET TO THE SIDE. REPORTEDLY, DURING ATTEMPTED MEDIAL DEPLOYMENT OF TWO ADDITIONAL PROGLIDE DEVICES, THE SUTURE DID NOT ENGAGE WITH THE VESSEL AND PULLED OUT OF FROM THE ARTERY WHEN THE DEVICE WAS RETRACTED TO HARVEST THE SUTURE. A SKIN NICK INCISION WAS MADE AND THE SUBCUTANEOUS TISSUE TRACT WAS ENLARGED TO ENSURE ALL SUTURE WAS REMOVED. THE OPERATOR USED THE GUIDE WIRE THAT REMAINED IN THE VESSEL TO DEPLOY ANOTHER PROGLIDE DEVICE. THE SUTURES WERE SET TO THE SIDE AND THE ACCESS SITE WAS UPSIZED TO AN 8-FRENCH THAN A 20-FRENCH TO ACCOMMODATE THE EVAR DELIVERY CATHETER. AFTER COMPLETION OF THE EVAR PROCEDURE, THE KNOTS FROM THE TWO PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN DID NOT BELIEVE THAT THE DEVICES MALFUNCTIONED BUT THAT THE REPORTED EXPERIENCE WAS RELATED TO THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ENDOVASCULAR AORTIC ANEURYSM REPAIR PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN THE RIGHT COMMON FEMORAL ARTERY THROUGH AN UNSPECIFIED SIZED ACCESS SITE USING TWO PROGLIDE DEVICES. REPORTEDLY, THE SUTURES HAD NOT ENGAGED. A CUTDOWN WAS PERFORMED TO RETRIEVE THE SUTURE. IT WAS NOT SPECIFIED HOW HEMOSTASIS WAS ACHIEVED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THERE WAS A REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTEDLY 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
    213141 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SHEATHS: 6-FRENCH, 8-FRENCH, AND 20-FRENCH