BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4251044 · Received November 14, 2014

    Report

    Report Number
    2024168-2014-07454
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT CALCIFICATION WAS NOTED IN A COMMON FEMORAL ARTERY AND A 4FR VENOUS SHEATH WAS USED NEXT TO THE ARTERIAL SHEATH. 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 OR PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED FAILURE TO DEPLOY THE FOOT WAS NOT CONFIRMED. DURING THE DEVICE ANALYSIS, THE FOOT WAS FULLY DEPLOYED AND COMPLETELY RETRACTED VIA OPENING AND CLOSING THE LEVER WITHOUT ANY OBSERVABLE RESISTANCE. BASED ON A VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WITH PROGLIDE DEVICES WERE ATTEMPTED IN A COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, AN ATTEMPT WAS MADE TO DEPLOY THE FOOT; HOWEVER, THE LEVER COULD NOT BE LIFTED ALTHOUGH SOME FORCE WAS APPLIED. A SECOND PROGLIDE DEVICE WAS SUCCESSFULLY PLACED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE; HOWEVER, NOT ESTABLISHED IN THE PRECLOSE TECHNIQUE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. THE ARTERIOTOMY CLOSURE WAS ATTEMPTED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS SMALLER SHEATH (SIZE UNKNOWN) AND DURING THE TAVI PROCEDURE THE SHEATH WAS UPSIZED TO 16F. A SECOND AND THIRD PROGLIDE DEVICE WERE SUCCESSFULLY PLACED USING THE PRECLOSE TECHNIQUE. THE TAVI PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED USING THE PRE-PLACED SUTURES OF THE TWO PROGLIDE DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737332 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40514K1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention SHEATH: 16FR, 4FR (VENOUS SHEATH) HEPARIN