BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3973451 · Received August 1, 2014

    Report

    Report Number
    2024168-2014-04912
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 7, 2014
    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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER FOUR PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS ENDOVASCULAR AORTIC REPAIR (PEVAR) PROCEDURE, SUTURE PLACEMENT WAS ATTEMPTED IN THE LEFT COMMON FEMORAL ARTERY WITH A PROGLIDE DEVICE USING THE PRECLOSE TECHNIQUE. THE FIRST PROGLIDE EXHIBITED PULSATILE FLOW AND DEPLOYED NORMALLY WITHOUT RESISTANCE. THE SECOND PROGLIDE DEVICE SHOWED PULSATILE BLOOD FLOW, BUT UPON RETRACTION CAME RIGHT OUT AS IF THE FOOT PLATE WAS DEPLOYED OUTSIDE THE ARTERY. THE DEVICE WAS EXCHANGED OVER A WIRE AND A THIRD PROGLIDE WAS INSERTED AND DEPLOYED NORMALLY. THE ARTERIOTOMY WAS 6F. THE SHEATH WAS UPSIZED TO 9F AND 18F FOR THE PEVAR PROCEDURE. THE PEVAR WAS PERFORMED AND COMPLETED. THE TWO SUCCESSFULLY PREPLACED SUTURES DID NOT ACHIEVE COMPLETE HEMOSTASIS. A FOURTH PROGLIDE DEVICE WAS USED AND BEHAVED AS THE SECOND DEVICE, WHERE UPON RETRACTION, THE FOOTPLATE APPEARED TO DEPLOY OUTSIDE OF THE ARTERY AND THE DEVICE DID NOT OFFER RESISTANCE WHEN IT SHOULD HAVE. THE DEVICE WAS EXCHANGED FOR A FIFTH PROGLIDE WHICH PERFORMED NORMALLY BUT STILL HEMOSTASIS WAS NOT ACHIEVED. A CUT DOWN WAS PERFORMED TO REMOVE THE FIFTH PROGLIDE DEVICE AND FOUND THAT BOTH THE ANTERIOR AND POSTERIOR PORTION OF THE FOOT WERE OBSERVED TO BE EXTRAVASCULAR (IN FASCIA). HEMOSTASIS WAS ACHIEVED WITH SURGICAL INTERVENTION. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY DUE TO THE CUT DOWN AFTER THE FIFTH DEVICE. THE PHYSICIAN IS REPORTEDLY IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE AND IS ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN WAS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE AND THE PRECLOSE TECHNIQUE. ALSO, WHEN THE CUT DOWN WAS PERFORMED TO REMOVE THE FIFTH PROGLIDE DEVICE IT WAS FOUND THAT BOTH THE ANTERIOR AND POSTERIOR PORTION OF THE FOOT WERE OBSERVED TO BE EXTRAVASCULAR (IN FASCIA) AND THE DEVICE WAS DIFFICULT TO REMOVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451030 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40411K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 9F, 18F, HEPARIN