BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1842257 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01957
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    November 7, 2007
    Report Date
    November 7, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY - THE RETURNED DEVICE WAS REC'D PARTIALLY DEPLOYED. BOTH NEEDLES WERE SUCCESSFULLY CAPTURED BY THEIR RESPECTIVE CUFFS. THE LINK MATERIAL WAS NORMAL. THE END OF THE RAIL SUTURE APPEARED TO HAVE BEEN CUT. THE NON-RAIL PORTION OF THE SUTURE WAS NOT RETURNED. THERE WERE NO ABNORMAL OBSERVATIONS OR MALFUNCTION DETECTED. BASED ON THE FINDINGS, THE DEVICE CONFORMED TO SPECIFICATION. A ROOT CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. NO MFG OR QUALITY ISSUE WAS DETECTED. A 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 IN-TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE USING A PRE-CLOSE TECHNIQUE OF THE SUPERFICIAL FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, ALTHOUGH, HEAVY BLEEDING LEAKED "BESIDE" THE SHEATH AND A "VERY SMALL" HEMATOMA STARTED TO DEVELOP, AN ATTEMPT WAS MADE TO DEPLOY THE DEVICE. "BECAUSE OF THE HEMATOMA IT WAS NOT POSSIBLE TO FINISH THE PROCEDURE AND TO CLOSE WITH THE PERCLOSE PROPERLY." MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT THE PT WAS HYPERTENSIVE (213/121) DURING THE PROCEDURE, WHICH MAY HAVE CONTRIBUTED TO THE BLEEDING BESIDE THE SHEATH. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 51054-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention