BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3772249 · Received April 25, 2014

    Report

    Report Number
    2024168-2014-02600
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTEDLY, THE PROGLIDE DEVICES WERE USED IN A MODERATELY CALCIFIED RIGHT COMMON FEMORAL ARTERY. THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING SPECIAL PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. (B)(4) - INDICATION FOR USE - REPORTEDLY A 24F SHEATH WAS USED IN THE PROCEDURE. PER INSTRUCTIONS FOR USE, UNDER INDICATIONS FOR USE: THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21F SHEATHS. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE FOUR OTHER PERCLOSE PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. REPORTEDLY, THE SHEATH WAS UPSIZED TO 24F. THE INSTRUCTIONS FOR USE, UNDER INDICATIONS, STATES: THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21F SHEATHS. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE, THE SUTURES OF TWO PROGLIDE DEVICES WERE PLACED USING THE PRECLOSE TECHNIQUE IN THE MODERATELY CALCIFIED RIGHT COMMON FEMORAL ARTERY. THE ARTERIOTOMY WAS 7F. DURING THE TEVAR PROCEDURE THE SHEATH WAS UPSIZED TO A 14F THEN TO A 24F. AT THE END OF THE PROCEDURE, THE SUTURES DID NOT ACHIEVE HEMOSTASIS. THREE ADDITIONAL PROGLIDE DEVICES WERE DEPLOYED, BUT HEMOSTASIS WAS NOT ACHIEVED. A SURGICAL CUT-DOWN WAS PERFORMED TO ACHIEVE HEMOSTASIS. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY OF 45 MINUTES IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE BUT IS NOT ESTABLISHED IN THE PRECLOSE DEPLOYMENT TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252437 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30905K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7F, 14, MEDTRONIC 24F, ASPIRIN, PLAVIX