BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3103130 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02912
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SUTURE BREAK WAS NOT CONFIRMED; ANALYSIS OF THE DEVICE INDICATED THAT A POSTERIOR NEEDLE-TO-CUFF MISS AND ANTERIOR NEEDLE-TO-CUFF DETACHMENT OCCURRED, WHICH CAN APPEAR SIMILAR TO THE OPERATOR AS A SUTURE BREAK. THE POSTERIOR NEEDLE-TO-CUFF MISS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE ANTERIOR NEEDLE CAUSING DAMAGE TO THE ANTERIOR CUFF TABS. ONE OF THE THREE ANTERIOR CUFF TABS (MEASURING APPROXIMATELY 0.01 BY 0.01 INCHES SQUARE) DETACHED FROM THE ANTERIOR CUFF AND WAS NOT RETURNED WITH THE DEVICE. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC CORONARY ANGIOGRAM, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, THE SUTURE BROKE. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. EVALUATION OF THE DEVICE REVEALED THAT ONE OF THE THREE ANTERIOR CUFF TABS DETACHED AND WAS NOT RETURNED WITH THE DEVICE. THE PHYSICIAN WAS AWARE OF THE ANTERIOR CUFF TAB DETACHMENT AT THE TIME IT WAS REPORTED AND INDICATED THERE WERE NO PATIENT COMPLICATIONS AND NO ADDITIONAL MEDICAL PLAN OF TREATMENT OTHER THAN THE ROUTINE POST-PROCEDURE DISCHARGE INSTRUCTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204441 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21025J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6-FRENCH