BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2231185 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06074
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIALLY THE DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, THE CUSTOMER HAS REPORTED THE DEVICE WAS DISCARDED. THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE REPORTED EVENT. A SUTURE BREAK CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, USER TECHNIQUE OR PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, SUTURE STRENGTH IS TESTED, ASSEMBLED AND LOADED INTO THE DEVICE. IN ADDITION, SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED PER FUNCTIONAL TEST TO VERIFY THE FUNCTIONALITY OF THE DEVICE. SUTURE MAY BREAK IF THE USER APPLIES TOO MUCH TENSION WHILE PULLING ON THE LIMB SUTURE. NO INFORMATION ABOUT USER TECHNIQUE WAS PROVIDED. A FEMORAL ANGIOGRAM WAS TAKEN AND REPORTEDLY NO CALCIFICATION WAS NOTED. NO OTHER INFORMATION ABOUT PATIENT ANATOMICAL CONDITION WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT WAS PERFORMED AND FOUND NO OTHER SIMILAR INCIDENTS. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER A RENAL ANGIOGRAM PROCEDURE. REPORTEDLY, AFTER THE DEVICE WAS DEPLOYED, A SUTURE BREAK OCCURRED. THE PROGLIDE WAS REMOVED FROM THE ANATOMY AND HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 060496H

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SHEATH: 6F