BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1924014 · Received December 14, 2010

    Report

    Report Number
    2953144-2010-03223
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE ANTERIOR AND POSTERIOR CUFFS SUCCESSFULLY CAPTURED THEIR RESPECTIVE NEEDLES DURING NEEDLE DEPLOYMENT; HOWEVER, THE LINK WAS PULLED FROM POSTERIOR CUFF DURING NEEDLE PLUNGER RETRACTION. THE LINK PULL WOULD SUBSEQUENTLY RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING PLUNGER RETRACTION AND CAN APPEAR VERY SIMILAR TO THE REPORTED NEEDLE-TO-CUFF MISS. DURING LAB TESTING, THE NEEDLE PLUNGER WAS REINSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY RESISTANCE THAT COULD CONTRIBUTE TO THE LINK BEING PULLED FROM POSTERIOR CUFF. ADDITIONALLY, THE WHOLE SUTURE COULD BE PULLED OUT FROM THE DEVICE WITHOUT ANY OBSERVABLE RESISTANCE TO SUGGEST POSSIBLE SUTURE DRAG THAT MIGHT HAVE OCCURRED BECAUSE OF THE LINK BEING PULLED DURING NEEDLE PLUNGER RETRACTION. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE LINK PULLED FROM POSTERIOR CUFF COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A 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. PROGLIDE DEVICE #2 (PART 12673-03; LOT 920226H) AND PROGLIDE DEVICE #3 (PART 12673-03; 920516H) INDICATED ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    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 THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, THERE WAS NO SUTURE ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED AND A SECOND AND THIRD PROGLIDE WERE ATTEMPTED BUT ALSO RESULTED IN A NEEDLE-TO-CUFF MISS. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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-REDWOOD CITY 920226H

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention