BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3103396 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02923
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SUTURE RETRIEVAL ISSUE WAS CONFIRMED. HOWEVER, ANALYSIS OF THE RETURNED DEVICE INDICATED THAT ONE OF THE THREE ANTERIOR CUFF TABS (MEASURING APPROXIMATELY 0.01 BY 0.01 INCHES) WAS BROKEN OFF 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PATIENT WAS REPORTED TO BE MORBIDLY OBESE. THE PERCLOSE PROGLIDE SMC DEVICE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENTS POPULATIONS WHO ARE MORBIDLY OBESE (BODY MASS INDEX GREATER THAN 35 KG/M2). 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

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: EVALUATION OF THE RETURNED PROGLIDE DEVICE FOUND THAT ONE OF THE THREE ANTERIOR CUFF TABS (MEASURING APPROXIMATELY 0.01 BY 0.01 INCHES) WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. THE REPORTER WAS CONTACTED AND INDICATED THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERCUTANEOUS CORONARY INTERVENTION, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A SUTURE RETRIEVAL ISSUE OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED NO SUTURE WAS ATTACHED. THE DEVICE WAS REMOVED AND A NON-ABBOTT 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203869 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30220K1

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SHEATH: 6-FRENCH, ANGIOMAX