BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4243308 · Received November 11, 2014

    Report

    Report Number
    2024168-2014-07329
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VENOUS SHEATH WAS REPORTEDLY USED NEXT TO THE ARTERIAL SHEATH IN THE LEFT COMMON FEMORAL ARTERY. THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER PERCLOSE PROGLIDE DEVICE REFERENCED WAS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED IN THE LEFT COMMON FEMORAL ARTERY (LCFA) AND THE RIGHT COMMON FEMORAL ARTERY (RCFA) USING THE PRECLOSE TECHNIQUE PRIOR TO A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. THE ARTERIOTOMY WAS 6FR IN THE LCFA. REPORTEDLY, THE RAIL SUTURE SNAPPED ON THE DEVICE USED IN THE LCFA. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE ARTERIOTOMY WAS A 6FR IN THE RCFA AND DURING THE INTERVENTIONAL PROCEDURE, THE SHEATH WAS UPSIZED TO A 14FR. REPORTEDLY, THE RAIL SUTURE SNAPPED IN THE RCFA. THE PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED WITH MANUAL ARTERIAL COMPRESSION. FOLLOWING THE PROCEDURE IT WAS NOTICED THAT SWELLING OCCURRED IN THE PATIENT'S SCROTUM AND HAD TURNED BLACK REVEALING A HEMATOMA. MANUAL COMPRESSION WAS APPLIED TO SUCCESSFULLY TREAT THE HEMATOMA. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725457 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 14F