BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2143345 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04546
    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
    IL, 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 WAS NOT RETURNED FOR ANALYSIS. THE LOT NUMBER WAS NOT 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. WITHOUT DEVICE EVALUATION, A CAUSE FOR THE INABILITY TO REMOVE THE PLUNGER COULD NOT BE DETERMINED. A FACTOR CONTRIBUTING TO A DIFFICULT PLUNGER REMOVAL MAY OCCUR WHEN THE STEPS TO DEPLOY THE DEVICE ARE PERFORMED OUT OF SEQUENCE. BASED ON THE INFORMATION AVAILABLE AND THE INSPECTION CRITERIA, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND THE DEVICE WAS NOT RETURNED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER THE NEEDLES WERE DEPLOYED, THE PLUNGER STOPPED MID-WAY AS IT WAS BEING REMOVED. THE PHYSICIAN STATED THAT THE PLUNGER FELT TIGHT AND FURTHER PULLING DID NOT SEEM APPROPRIATE. THE LEVER WAS RETURNED TO THE ORIGINAL POSITION RETURNING THE FOOT TO THE ORIGINAL POSITION. THE GUIDE WIRE WAS REINSERTED. THE DEVICE COULD NOT BE REMOVED AS IT WAS THOUGHT ONE OF THE SUTURES SEEMED TO BE STUCK TO THE ARTERY. THE SUTURE WAS CUT AND THE DEVICE WAS REMOVED. A NEW SHEATH WAS PLACED OVER THE WIRE INTO THE FEMORAL ARTERY. AN ANGIOGRAM WAS PERFORMED AND IT WAS CONFIRMED THAT THERE WAS NO DISSECTION. MANUAL ARTERIAL PRESSURE WAS HELD TO ACHIEVE HEMOSTASIS. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention