BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2231589 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06082
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PLUNGER, LINK, ANTERIOR CUFF, AND ANTERIOR NEEDLE WERE NOT RETURNED WITH THE DEVICE. THE SCOPE OF THIS INVESTIGATION WAS LIMITED. INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE POSTERIOR CUFF SUCCESSFULLY CAPTURED THE POSTERIOR NEEDLE DURING THE PLUNGER DEPLOYMENT. HOWEVER, THE LINK WAS PULLED FROM THE SWAGE END OF THE POSTERIOR CUFF WHEN RETRACTING THE NEEDLE PLUNGER, WHICH SUBSEQUENTLY RESULTED IN A FAILURE TO RETRIEVE THE SUTURE AND COULD APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. THEREFORE, THE REPORTED PRODUCT EXPERIENCE IS CONFIRMED. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. A LINK PULL SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. POSSIBLE CONTRIBUTING FACTORS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. THE SUTURE WAS RETURNED INTACT. THERE WAS NO INDICATION THAT IT WAS DRAGGED THROUGH THE DEVICE OR SUTURE BEARING WHILE RETRACTING THE NEEDLE PLUNGER, WHICH COULD HAVE CONTRIBUTED TO A LINK PULL. EVERY LINK ASSEMBLY IS APPROPRIATELY INSPECTED AND TESTED FOR PROPER ASSEMBLY DURING MANUFACTURING. DURING LAB TESTING, A PROXY PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. THERE WERE NO REPORTED CHALLENGING ANATOMICAL CONDITIONS WHICH COULD HAVE CONTRIBUTED TO A LINK PULL. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE NEEDLE PLUNGER WAS ABRUPTLY PULLED OUT OF THE DEVICE AFTER NEEDLE DEPLOYMENT, WHICH COULD CAUSE THE LINK TO BE PULLED FROM THE POSTERIOR CUFF. BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION, THE PROBABLE CAUSE FOR THE LINK PULL FROM THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. THE PROGLIDE DEVICE WAS REMOVED AND A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A THIRD PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 050296H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7FHEPARIN