BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1923386 · Received December 13, 2010

    Report

    Report Number
    2953144-2010-03211
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE INDICATED THAT THE PLUNGER HAD BEEN DEPRESSED TO DEPLOY THE NEEDLES AND THE POSTERIOR CUFF CAPTURED ITS NEEDLE TIP. THIS CONTRADICTED THE REPORTED INFORMATION THAT THE DEVICE WAS FORCIBLY REMOVED PRIOR TO DEPLOYING THE NEEDLES. THE RETURNED CONDITION IS CONSISTENT WITH THE DEVICE BEING FORCIBLY PULLED OUT OF THE PATIENTS ANATOMY AFTER DEPLOYING THE NEEDLES WITHOUT RETRACTING THE NEEDLE PLUNGER AND CLOSING THE FOOT. INSPECTION OF THE RETURNED DEVICE REVEALED A BROKEN POSTERIOR FOOT WHICH WAS NOT RETURNED. ALSO, THE POSTERIOR CUFF SUCCESSFULLY CAPTURED THE POSTERIOR NEEDLE DURING NEEDLE DEPLOYMENT, BUT THE POSTERIOR NEEDLE BROKE INTO 2 PIECES AND BOTH WERE RETURNED WITH THE DEVICE. THE OBSERVED DAMAGE IS CONSISTENT WITH AN INCOMPLETE BLOW-THROUGH CAUSED BY THE PLUNGER NOT BEING FULLY DEPRESSED TO EJECT THE POSTERIOR CUFF OUT OF THE POCKET. SUBSEQUENTLY, THE POSTERIOR CUFF PARTIALLY REMAINED IN THE POSTERIOR FOOT POCKET AFTER CAPTURING ITS NEEDLE, FORCEFUL PULLING OF THE DEVICE OUT OF THE PATIENTS ANATOMY PRIOR TO RETRACTING THE NEEDLE PLUNGER AND CLOSING THE FOOT RESULTED IN A POSTERIOR FOOT AND NEEDLE BREAK AS OBSERVED. ALSO, WHILE THE DEVICE WAS BEING PULLED OUT, THE PLUNGER WAS ALSO PARTIALLY RETRACTED FROM THE DEVICE, CAUSING THE ANTERIOR CUFF TO DETACH FROM ITS NEEDLE TIP AS INDICATED BY DAMAGED ANTERIOR CUFF TABS AND ANTERIOR NEEDLE BARB. BASED ON OUR INVESTIGATION, THE CAUSE FOR THE POSTERIOR FOOT AND NEEDLE BREAK IS INCORRECT DEPLOYMENT TECHNIQUE. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. (B)(4): USE IN CALCIFIED ARTERY AND USE OF EXCESSIVE FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER FOOT DEPLOYMENT, 'STRONG FORCE' WAS USED TO PULL THE DEVICE BY THE HANDLE AGAINST THE ARTERIAL WALL FOR FOOT POSITIONING. THE DEVICE WAS PULLED OUT OF THE ANATOMY WITH A PIECE OF TISSUE STUCK TO IT. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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-REDWOOD CITY 900136H

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention HEPARIN