BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2792645 · Received October 16, 2012

    Report

    Report Number
    2024168-2012-06522
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF FOOT BREAK AND SUTURE RETRIEVAL ISSUE WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE PROBABLE CAUSE FOR THE EVENT WAS DETERMINED TO BE MOST LIKELY RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE PROGLIDE AFTER A SUPERFICIAL FEMORAL ARTERY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. REPORTEDLY, THE PLUNGER WAS PRESSED DOWN AND NO UNUSUAL RESISTANCE WAS FELT. THE PLUNGER AND NEEDLES WERE REMOVED FROM THE DEVICE BODY AND NO SUTURE WAS ATTACHED TO THE NEEDLES. THE SYSTEM WAS WITHDRAWN FROM THE PATIENT AND MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. AFTER REMOVAL OF THE PROGLIDE A SMALL PART OF THE FOOT WAS NOTED TO BE MISSING. AS THE PATIENT WAS FINE AND IT WAS NOT POSSIBLE TO LOCATE THE MISSING PART OF THE FOOT NEAR THE PUNCTION SITE OR THE SUBDERMAL TISSUE, THE PROCEDURE WAS FINISHED AND NO FURTHER ATTEMPTS FOR RECOVERY WERE PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 20726J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6 FR HEPARIN