BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2192206 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05515
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, IT WAS INADVERTENTLY DISCARDED AT THE MANUFACTURING FACILITY PRIOR TO EVALUATION. A SUTURE BREAK CAN BE CAUSED BY A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO: USER TECHNIQUE, PATIENT ANATOMICAL CONDITIONS OR MANUFACTURING. THE SUTURE MAY BREAK IF THE USER APPLIES TOO MUCH TENSION WHILE PULLING ON THE LIMB SUTURE DURING PLUNGER AND NEEDLES REMOVAL FROM THE DEVICE BODY. PATIENT ANATOMICAL CONDITIONS MAY ALSO AFFECT THE REPORTED SUTURE BREAK. AS THE SUTURE MOVES THROUGH THE TISSUE UPON DEPLOYMENT, EXTRANEOUS TISSUE MAY BIND SUTURE AT KNOT THEREBY PREVENTING SMOOTH EXTRACTION THAT COULD LEAD TO THE SUTURE BREAK. HOWEVER, NO INFORMATION EXCEPT FOR NO ARTERIAL CALCIFICATION WAS REPORTED. NO RELEVANT INFORMATION ABOUT USER TECHNIQUE OR PATIENT ANATOMICAL CONDITIONS WERE PROVIDED THAT COULD HAVE BEEN EVALUATED AS A CONTRIBUTING FACTOR. PRIOR TO MANUFACTURING, EVERY SUTURE COMPONENT IS INSPECTED FOR DAMAGE AND LOT TESTING IS PERFORMED PRIOR TO BEING RELEASED FOR MANUFACTURING USE. THE LOT OF SUTURE USED IN THE BUILD OF PROGLIDE LOT 030176H WAS ACCEPTED FOR USE. THERE IS NO INDICATION THE SUTURE COMPONENT INFLUENCE THE SUTURE BREAK. A DEFINITIVE CAUSE FOR THE REPORTED SUTURE BREAKAGE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT DOES NOT APPEAR TO BE RELATED TO A MANUFACTURING QUALITY DEFICIENCY. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS REPORTED FOR A SUTURE BREAK FROM THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELEVANT NON-CONFORMING MATERIAL RECORD ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE AN INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. DURING MANUFACTURING, SUTURE STRENGTH IS TESTED, ASSEMBLED AND LOADED INTO THE DEVICE. IN ADDITION, SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE.

    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 RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A NON-CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, A DEVICE SUTURE BREAKAGE OCCURRED DURING IMPLANTATION. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 030176H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention