BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2770228 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06228
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 12, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DEVICE, REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBER. PATIENT AGE REPORTED AS LESS THAN 18 YEARS OLD. PATIENT SELECTION - THE PROGLIDE DEVICE WAS REPORTEDLY DEPLOYED IN A PATIENT YOUNGER THAN 18 YEARS OF AGE. THE INSTRUCTIONS FOR USE STATES IN THE SPECIAL PATIENT POPULATIONS SECTION THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS YOUNGER THAN 18 YEARS OF AGE. INDICATIONS FOR USE - THE DEVICE WAS REPORTEDLY DEPLOYED IN THE FEMORAL VEIN. THE INSTRUCTIONS FOR USE OF THE PROGLIDE DEVICE STATES UNDER INDICATIONS FOR USE THAT THE DEVICE IN INDICATED FOR PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENT WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR AND INTERVENTIONAL CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MEDWATCH FILED THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. 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. THE DEVICE WAS REPORTEDLY DEPLOYED IN A FEMORAL VENOUS ACCESS SITE, WHICH WAS UPSIZED TO 22F TO MATCH THE OUTER DIAMETER OF THE DELIVERY CATHETER. THE PERCLOSE PROGLIDE DEVICE INSTRUCTIONS FOR USE STATE UNDER INDICATIONS FOR USE THAT THE DEVICE IN INDICATED FOR PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENT WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR AND INTERVENTIONAL CATHETERIZATION PROCEDURES UTILIZING A 5F OR 8F PROCEDURAL SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A MELODY TRANSCATHETER PULMONARY VALVE REPLACEMENT, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED OF THE COMMON FEMORAL VEIN USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING SUTURE DEPLOYMENT OF THE FIRST PROGLIDE DEVICE THROUGH A 6-FRENCH SIZED ACCESS SITE, WHEN THE NEEDLE PLUNGER WAS RETRACTED, NO SUTURE WAS PRESENT ON THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND DEPLOYMENT OF A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT WHEN THE NEEDLE PLUNGER WAS REMOVED NO SUTURE WAS ALSO PRESENT ON THE NEEDLES. THE DEVICE WAS REMOVED AND THE SUTURES OF TWO ADDITIONAL PROGLIDE DEVICES WERE SEQUENTIALLY DEPLOYED 60 DEGREES OPPOSITE IN ORIENTATION AND SET TO THE SIDE. THE ACCESS SITE WAS DILATED TO 22-FRENCH TO MATCH THE OUTER DIAMETER OF THE DELIVERY CATHETER. AFTER CONCLUSION OF THE MELODY TRANSCATHETER PULMONARY VALVE REPLACEMENT, 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 IS 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATHS: 6-FRENCH, 22-FRENCH