BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3103277 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02915
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EXPERIENCE WAS CONFIRMED. THE VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE DID NOT DETECT A QUALITY DEFICIENCY. A FEMORAL ANGIOGRAM WAS NOT PERFORMED PRIOR TO DEVICE DEPLOYMENT AS INDICATED IN THE INSTRUCTIONS FOR USE TO EVALUATE THE FEMORAL ARTERY SITE FOR SIZE, CALCIUM DEPOSITS, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL TO AVOID POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - FAILURE TO FOLLOW INSTRUCTIONS. REPORTEDLY, THE OPERATOR DID NOT PERFORM A FEMORAL ANGIOGRAM PRIOR TO DEVICE DEPLOYMENT. THE INSTRUCTIONS FOR USE (IFU) STATE UNDER ARTERIAL SITE AND PUNCTURE CONSIDERATIONS AND SMC DEVICE PLACEMENT TO PERFORM A FEMORAL ANGIOGRAM PRIOR TO DEPLOYMENT OF THE PERCLOSE PROGLIDE SMC DEVICE TO EVALUATE THE FEMORAL ARTERY SITE FOR SIZE, CALCIUM DEPOSITS, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL TO AVOID POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY. THE OTHER PERCLOSE PROGLIDE DEVICE IS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    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. THE OPERATOR DID NOT PERFORM A FEMORAL ANGIOGRAM PRIOR TO THE CLOSING PROCEDURE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT ALSO RESULTED IN A NEEDLE-TO-CUFF MISS. MANUAL ARTERIAL COMPRESSION WAS APPLIED 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203467 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30129J2

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SHEATH: 6-FRENCH