BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2231098 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06073
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 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
    OH, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE COMPLAINT. 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 AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. THE 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 NO CALCIFICATION WAS NOTED. A CONCLUSIVE CAUSE TO THE REPORTED SUTURE BREAK COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND FOUND NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE REVIEW OF THE DATABASES, EVENT INFORMATION AND TESTING/INSPECTION CRITERIA FOR THIS LOT, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    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 AN INTERVENTIONAL LEFT HEART CATHETERIZATION. REPORTEDLY, WHEN THE PLUNGER WAS REMOVED A SUTURE BREAK OCCURRED. THE VESSEL WAS RE-WIRED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN WAS REPORTEDLY 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 050186H

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SHEATH: 6F