BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2033039 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02142
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) INCORRECT ANATOMY THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED AND THEREFORE, A THOROUGH ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER SIMILAR INCIDENTS REPORTED FOR THIS LOT.

    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 RIGHT EXTERNAL ILIAC ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR A LEFT HEART CATHETERIZATION PROCEDURE. A ROTOR BLADE WAS USED. THE PATIENT WAS REPORTED TO HAVE ALREADY HAD A PRE-EXISTING SELF EXPANDING STENT (40 MM) IN THE ILIAC ARTERY. AFTER THE INTERVENTIONAL PROCEDURE, THE PHYSICIAN WENT TO CLOSE THE SITE (RIGHT EXTERNAL ILIAC) WITH A PROGLIDE DEVICE. THE DEVICE DEPLOYED CORRECTLY, BUT HEMOSTASIS WAS NOT ACHIEVED. THERE WAS RETRO PERINEAL BLEEDING AT THE SITE. MANUAL COMPRESSION WAS HELD AND A NON-ABBOTT DEVICE WAS USED. THE PATIENT'S CONDITION STARTED TO DETERIORATE (LOW BLOOD PRESSURE) AND HE WAS RUSHED INTO THE CATH LAB. A COVERED STENT WAS THEN INSERTED AT THE PUNCTURE SITE. THE PATIENT THEN 'CRASHED' AND COULD NOT BE REVIVED. THE PATIENT WAS REPORTED TO HAVE EXPIRED. THE PATIENT WAS REPORTED TO HAVE EXTENSIVE PERIPHERAL VASCULAR DISEASE AND MANY PRIOR ARTERIOTOMY AND DEVICE CLOSURE PROCEDURES. 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-TEMECULA-CT 930296H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death