BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1870223 · Received October 11, 2010

    Report

    Report Number
    2953144-2010-02445
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ABBOTT VASCULAR-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 2 UNUSED REPRESENTATIVE SAMPLES WITH THE SAME PART NUMBER AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. 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 PERFORATION OCCURRED DURING STENTING OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH A NON-ABBOTT STENT, WHICH REQUIRED TREATMENT WITH A GRAFTMASTER STENT. ALTHOUGH THE PERFORATION WAS TREATED SUCCESSFULLY, THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY, AND HAD A CEREBRAL VASCULAR ACCIDENT AND EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN PULLING THE PLUNGER BACK AND REMOVING THE NEEDLES FROM THE DEVICE, ONE OF THE SUTURES WAS BROKEN. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. NO ADVERSE PT EFFECTS WERE REPORTED. THOUGH REQUESTED, 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 ABBOTT VASCULAR-REDWOOD CITY NA 91006-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention