BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2143396 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04548
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT DEVICE EVALUATION, A CAUSE FOR THE REPORTED SUTURE BREAK COULD NOT BE DETERMINED. A SUTURE BREAK CAN BE CAUSED BY A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO MANUFACTURING, TOO MUCH TENSION WAS APPLIED, OR THE SUTURE WAS NICKED. THIS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE EVENT, BUT CANNOT BE CONFIRMED. TO ASSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF SUTURES ARE TESTED UNDER STRESS FOR DIAMETER MEASUREMENTS BEFORE RELEASE TO MANUFACTURING. A SAMPLING OF FINISHED DEVICES ARE TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS RELATED TO THIS EVENT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD, 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. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHILE ADVANCING THE KNOT WITH THE KNOT PUSHER, THE SUTURE SNAPPED. AS THE GUIDE WIRE REMAINED IN PLACE, ANOTHER PROGLIDE WAS INSERTED AND USED TO ACHIEVE HEMOSTASIS. THE PATIENT EXPERIENCED PAIN IN THE TARGET GROIN DURING AND SHORTLY AFTER THE CLOSING PROCEDURE. THE PAIN HAD RESOLVED THE SAME DAY WITHOUT TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA. REPORTEDLY,THE PHYSICIAN IS PROFICIENT IN THE USE OF THE 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 040286H

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 6F SHEATH