BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1901861 · Received November 17, 2010

    Report

    Report Number
    2953144-2010-02854
    Event Type
    Injury
    Date Received
    November 17, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (CONTINUED): HEPARIN. THE PERCLOSE PROGLIDE (PART# 12673-03, LOT# 920106H), IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.(B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE LINK, MONOFILAMENT, POSTERIOR CUFF AND NEEDLE TIP WERE NOT RETURNED. THE ANTERIOR CUFF WAS STILL ENGAGED TO THE ANTERIOR NEEDLE TIP. BASED ON THE INVESTIGATION FINDINGS, THE LINK WAS PULLED FROM THE ANTERIOR CUFF. THE LINK CONNECTS THE ANTERIOR NEEDLE TO THE SUTURE; IF THE LINK DETACHES FROM THE CUFF, THE SUTURE WILL NOT BE PRESENT DURING PLUNGER WITHDRAWAL AND CAN APPEAR VERY SIMILAR TO A CUFF MISS. THE LINK DETACHMENT IS LIKELY THE RESULT OF RESISTANCE OR DRAG ENCOUNTERED DURING THE PROCEDURE. THE PATIENT ANATOMICAL CONDITION MAY HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE; HOWEVER, THERE WAS NO INFORMATION PROVIDED ABOUT THE PATIENT ANATOMY AS A CONTRIBUTING FACTOR. THEREFORE, THE ROOT CAUSE FOR THE LINK BREAK FROM THE CUFF IS COULD NOT BE DETERMINED. 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.

    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 LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, 2 PROGLIDES FAILED, NO SUTURE WAS ATTACHED TO THE NEEDLES OF THE DEVICES. HEMOSTASIS WAS ACHIEVED USING A STARCLOSE SE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. (B)(4) HAD THE PATIENT CYCLE POWER TWICE TO CLEAR THE ERROR AND START OVER WITH NEW SUPPLIES. THE PATIENT EXPLAINED THIS WAS HIS LAST SET OF SUPPLIES. (B)(4) SUGGESTED AN EMERGENCY SUPPLY DELIVERY, BUT THE PATIENT ELECTED TO END THERAPY FOR THE NIGHT AND CONTACT THEIR DIALYSIS NURSE IN THE MORNING. THE PATIENT EXPLAINED HE COMPLETED THERAPY LAST NIGHT AND SHOULD BE OK TO MISS TONIGHT'S THERAPY. (B)(4) ASSISTED THE PATIENT IN REMOVING THE SUPPLIES. (B)(4) CONTACTED THE PATIENT'S DIALYSIS NURSE WHO ADVISED THEY SAW THE PATIENT IN CLINIC (B)(6) BUT THE PATIENT DID NOT MENTION THE ERROR. (B)(4) EXPLAINED THE ERROR AND THE NURSE AGREE TO FOLLOW-UP WITH THE PATIENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 PERCLOSE PROGLIDE (PART# 12673-03, LOT#920106H)