BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2143154 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04529
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    January 27, 2011
    Report Date
    June 6, 2011
    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). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT IT WAS IN THE PRE-PLUNGER DEPLOYMENT CONDITION. BLOOD WAS PRESENT IN THE DEVICE. THESE FINDINGS ARE CONSISTENT WITH THE REPORTED EXPERIENCE OF HOW THE DEVICE COULD NOT BE INSERTED INTO THE VESSEL OR INSERTED OVER THE GUIDE WIRE RESULTING IN A FAILURE TO ACHIEVE HEMOSTASIS. BASED ON THE REPORTED EXPERIENCE, THE SHEATH WAS INSPECTED AND THE COATING WAS PRESENT AND NOT A CONTRIBUTING FACTOR IN THE EVENT. THE DEVICE WAS THEN LOADED ONTO A PROXY 0.035 INCH GUIDE WIRE AND STOPPED APPROXIMATELY 2.5 CM PROXIMAL OF THE DISTAL TIP. THE GUIDE WIRE WAS LOADED VIA THE EXIT RAMP AND STOPPED APPROXIMATELY 5.5 CM DISTAL OF THE EXIT RAMP. DURING TESTING, THE SECTION OF THE STOPPAGE WAS EXAMINED AND COAGULATED BLOOD AND TISSUE WERE FOUND AT THE DISTAL END OF THE SHEATH PREVENTING THE GUIDE WIRE FROM LOADING DURING TESTING. AFTER THE DRIED BLOOD AND TISSUE WERE CLEARED THE GUIDE WIRE PASSED WITHOUT DIFFICULTY. THE DRIED BLOOD AND TISSUE WOULD NOT BE PRESENT DURING USE, BUT WOULD OCCUR DURING THE REPORTED FAILED ATTEMPT TO INTRODUCE THE DEVICE INTO THE PATIENTS ANATOMY. DIFFICULT SHEATH INSERTION CAN BE INFLUENCED BY A NUMBER OF FACTORS, BUT NOT LIMITED TO, TIGHT TISSUE TRACT, AN OBESE PATIENT, HEAVILY SCARRED PATIENT TISSUE, OR A TORTUOUS PATH. TO ASSURE DEVICES OPERATE ACCORDING TO SPECIFICATION, THE PATENCY OF THE GUIDE WIRE AND HYDROPHILIC COATING OF EACH DEVICE IS INSPECTED DURING MANUFACTURING. IN ADDITION A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO PREVIOUS INCIDENTS REPORTED FOR DIFFICULT TO INSERT SHEATH FOR THIS LOT. BASED ON THE ANALYSIS, THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED EXPERIENCE OF DIFFICULTY INSERTING THE DEVICE COULD NOT BE CONFIRMED. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY INTRODUCING THE DEVICE COULD NOT BE DETERMINED. THE REPORTED DIFFICULTY APPEARS TO BE RELATED TO THE OPERATIONAL INFLUENCES DURING USE AND NOT A PRODUCT QUALITY DEFICIENCY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE COULD NOT BE INSERTED INTO THE VESSEL. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT SEQUELA. REPORTEDLY THE PHYSICIAN IS TRAINED 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 920256H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention