BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2990358 · Received March 5, 2013

    Report

    Report Number
    2024168-2013-01281
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 PATIENT WAS REPORTED TO BE MORBIDLY OBESE WITH A BODY MASS INDEX OF (B)(6). PER THE SPECIAL PATIENT POPULATIONS SECTION OF THE PERCLOSE PROGLIDE DEVICE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAS NOT BEEN ESTABLISHED IN THE PATIENT POPULATIONS WHO ARE MORBIDLY OBESE WITH A BODY MASS INDEX GREATER THAN (B)(6). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED NEEDLE-TO-CUFF MISS WAS CONFIRMED. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING 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 AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ACHIEVED OF THE RIGHT COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES THROUGH A 6-FRENCH SIZED ACCESS SITE. REPORTEDLY, DURING DEPLOYMENT OF THE INITIAL PROGLIDE DEVICE A NEEDLE-TO-CUFF MISS OCCURRED. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND THE SUTURES FROM TWO ADDITIONAL PROGLIDE DEVICES WERE SEQUENTIALLY DEPLOYED 60 DEGREES OPPOSITE IN ORIENTATION AND SET TO THE SIDE. THE ACCESS SITE WAS DILATED TO 18-FRENCH TO MATCH THE OUTER DIAMETER OF THE DELIVERY CATHETER. AFTER CONCLUSION OF THE AAA REPAIR PROCEDURE, THE KNOTS FROM THE TWO 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
    94010 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20604J1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHEATH: 6-FRENCH