BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2944177 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00638
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE ANALYSIS OF THE RETURNED DEVICE INDICATES THAT A POSTERIOR CUFF MISS OCCURRED AND THIS CONFIRMED THE REPORTED EXPERIENCE. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, PROBABLE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. 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. THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT WAS REPORTED THE RIGHT COMMON FEMORAL ARTERY WAS MILDLY CALCIFIED. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. 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. THE OTHER TWO PERCLOSE PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLACEMENT OF THE PROGLIDE SUTURES WERE ATTEMPTED IN A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A ENDOVASCULAR AORTIC REPAIR PROCEDURE (EVAR). THE ARTERIOTOMY WAS A 8FR. REPORTEDLY, WHEN THE PLUNGER WAS REMOVED, NO SUTURES WERE ATTACHED. DURING THE PRECLOSE, A SECOND AND THIRD PROGLIDE DEVICES WERE USED WITH THE SAME RESULTS. A FOURTH PROGLIDE WAS REPLACED TO ACHIEVE HEMOSTASIS AT THE END OF THE INDEX PROCEDURE, WHERE THE SHEATH WAS UPSIZED TO A 20FR. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED, BUT NOT CERTIFIED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48447 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20427J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8 FR, 20FRHEPARIN