BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2160836 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04955
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE AND SUTURE WERE NOT RETURNED FOR INVESTIGATION. WITHOUT THE DEVICE OR SUTURE TO EXAMINE, NO DETERMINATION CAN BE MADE AS TO THE CONTRIBUTING FACTORS TO THE REPORTED SUTURE BREAK. THE RETURN OF THE DEVICE AND SUTURE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE PRODUCT EXPERIENCE. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT THE RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, SAMPLINGS OF FINISHED DEVICES ARE TESTED TO VERIFY FUNCTIONALITY OF THE DEVICE AND SAMPLINGS OF SUTURES ARE TESTED UNDER STRESS FOR DIAMETER MEASUREMENTS BEFORE RELEASE TO MANUFACTURING. POSSIBLE CONTRIBUTING FACTORS ARE MANUFACTURING, TOO MUCH TENSION APPLIED, OR THE SUTURE BEING NICKED; HOWEVER, THIS COULD NOT BE CONFIRMED. ULTIMATELY, THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS FROM THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE AND THE INSPECTION CRITERIA THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED AND COULD NOT PROVIDE THE LOT NUMBER; HOWEVER, THE INVESTIGATION IS NOT YET COMPLETED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE THROUGH A 6F SHORT SHEATH, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, DURING NEEDLE PLUNGER REMOVAL, THE SUTURE BROKE. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AND THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE OPERATOR WAS REPORTED TO BE TRAINED AND IS PROFICIENT IN THE USE OF THE PROGLIDE DEVICE. THOUGH REQUESTED, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention BRITE TIP SHORT SHEATH 6F