BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2250960 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06348
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE REVEALED A LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF DURING THE NEEDLE PLUNGER RETRACTION. A LINK BREAK WOULD RESULT 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 BREAK SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED DURING THE NEEDLE PLUNGER RETRACTION 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 BREAK. EVERY LINK ASSEMBLY IS APPROPRIATELY INSPECTED AND TESTED FOR PROPER ASSEMBLY DURING MANUFACTURING. FURTHERMORE, DURING 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 BREAK. ALSO, 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 HAVE CAUSED THE LINK TO BREAK. BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE LINK BREAK AT 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 LOT SPECIFIC 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED SUTURE PLACEMENT IN THE RIGHT AND LEFT COMMON FEMORAL ARTERY, USING THE PRECLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM PROCEDURE (AAA), THE PROGLIDE DEVICES MISFIRED AND WHEN THE DEVICES WERE REMOVED NO SUTURES WERE ATTACHED. THE PROGLIDES WERE REWIRED AND EXCHANGED FOR NEW PROGLIDE DEVICES TO ACHIEVE HEMOSTASIS. A 6F SHEATH WAS USED WHILE DEPLOYING THE PROGLIDE SUTURES AND THEN THE SHEATH WAS UPSIZED TO A 14F SHEATH TO PERFORM THE INTERVENTIONAL PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. 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 060106H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SHEATH: 6F, 14F