BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2831711 · Received November 14, 2012

    Report

    Report Number
    2024168-2012-07175
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    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). 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. IMPROPER OR INCORRECT PROCEDURE OR METHOD, FAILURE TO FOLLOW STEPS/INSTRUCTIONS. PER INSTRUCTIONS FOR USE: UNDER CLOSURE PROCEDURE - PERFORM A FEMORAL ANGIOGRAM THROUGH THE SIDE PORT OF THE PROCEDURAL SHEATH TO DETERMINE THE LOCATION OF THE ARTERIOTOMY SITE, THE VESSEL SIZE, AND THE PRESENCE OF DISEASE (CALCIFIED PLAQUE, STENOSIS, CHRONIC OR ACUTE OCCLUSION), TORTUOSITY OR PRESENCE OF ARTERIAL WALL DISSECTION. (B)(4) WILL BE ADDED FOR USE OF THE 12FR SHEATH, PER INSTRUCTIONS FOR USE, UNDER INDICATIONS FOR USE: THE PERCLOSE PROGLIDE 6F 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 5FR TO 8FR SHEATHS. THE OTHER PERCLOSE PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM 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 PLACEMENT OF THE PROGLIDE SUTURES WERE ATTEMPTED IN THE HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE BEFORE A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) INTERVENTIONAL PROCEDURE. THE ARTERIOTOMY WAS A 6FR AND DURING THE INTERVENTIONAL PROCEDURE THE SHEATH WAS UPSIZED TO AN 12FR SHEATH. REPORTEDLY, FOLLOWING THE INTERVENTIONAL PROCEDURE, NO ADEQUATE HEMOSTASIS COULD BE ACHIEVED BY LOCKING THE KNOT WITH THE SUTURE TRIMMER ON TWO PROGLIDE DEVICES. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE IN-TRAINING 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20907J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FR, 12FR HEPARIN