BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3872836 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03821
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - IMPROPER OR INCORRECT PROCEDURE OR METHOD, FAILURE TO FOLLOW STEPS. PER INSTRUCTIONS FOR USE, UNDER WARNINGS: DO NOT USE THE PERCLOSE PROGLIDE SMC SYSTEM IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA. PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. IT WAS REPORTED THAT CALCIFICATION WAS NOTED IN A COMMON FEMORAL ARTERY. THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATES THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE PLUNGER, SUTURE, LINK, NEEDLES AND CUFFS WERE NOT RETURNED. THE LEVER WAS OPENED AND THE FOOT WAS DEPLOYED. THE FOOT WAS EXAMINED AND THERE WERE NO NEEDLE TIP STRIKE MARKS NOTED. THE REPORTED SUTURE DETACHMENT WAS NOT CONFIRMED. THE PROGLIDE INSTRUCTIONS FOR USE STATES: DO NOT USE THE PERCLOSE PROGLIDE SMC SYSTEM IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA. PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NON-CONFORMING MATERIAL REPORTS 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 AN ARTERIOTOMY CLOSURE OF THE MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE WITH A 6FR SHEATH, AFTER A PERIPHERAL INTERVENTIONAL PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED. A SECOND PROGLIDE DEVICE WAS USED AND THE LEVER DID CLOSE; HOWEVER, THE DEVICE COULD NOT BE REMOVED FROM THE ARTERY. AT THAT TIME IT WAS NOTICED THAT THE ANTERIOR FOOT PLATE WAS STILL PARTIALLY OPEN. A REPORTED HIGH-STICK WAS DONE IN THE LEFT COMMON FEMORAL ARTERY. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. A CLINICALLY SIGNIFICANT DELAY CAUSED BY THE DEVICE WAS REPORTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350222 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40320K1

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SHEATH: 6FR