BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2083603 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03360
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE INDICATED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES DURING NEEDLE DEPLOYMENT. HOWEVER, THE LINK WAS PULLED FROM THE SWAGE END OF THE POSTERIOR CUFF WHILE RETRACTING THE NEEDLE PLUNGER. A LINK PULL WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING NEEDLE PLUNGER RETRACTION AND COULD APPEAR VERY SIMILAR TO THE REPORTED LINK-TO-CUFF DETACHMENT EXPERIENCE. LINK-TO-CUFF DETACHMENT INDICATED THAT THERE WAS RESISTANCE WHILE RETRACTING THE NEEDLE PLUNGER. HOWEVER, DURING LAB TESTING, THE PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE THAT COULD POTENTIALLY RESULT IN THE LINK DETACHING FROM THE POSTERIOR CUFF. ALSO, THERE WAS NO DAMAGE TO THE SUTURE TO SUGGEST THAT THE SUTURE MIGHT HAVE BEEN DRAGGED THROUGH THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE LINK-TO-CUFF DETACHMENT WHILE RETRACTING THE NEEDLE PLUNGER. BASED ON OUR INVESTIGATION, THE PROBABLE CAUSE FOR THE LINK PULL FROM THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. HOWEVER, CHALLENGING ANATOMICAL CONDITIONS COMBINED WITH ABRUPTLY PULLING OUT THE NEEDLE PLUNGER AFTER NEEDLE DEPLOYMENT COULD CONTRIBUTE TO LINK DETACHMENT, BUT THIS CAN NOT BE CONFIRMED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELEVANT NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A CORONARY STENTING PROCEDURE. REPORTEDLY, THE PLUNGER WAS RETRACTED FROM THE DEVICE BODY AND ONLY THE LINK WAS ATTACHED. THE DEVICE WAS REMOVED AND ANOTHER PROGLIDE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WAS NO CALCIFICATION NOTED AT THE ACCESS SITE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THOUGH REQUESTED, 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 910396H

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 6FR SHEATH, HEPARIN.