BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3771107 · Received April 24, 2014

    Report

    Report Number
    2024168-2014-02560
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 31, 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). IT WAS REPORTED THE DEVICE WAS USED IN A MILDLY 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. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED CUFF MISS COULD NOT BE CONFIRMED BECAUSE KEY COMPONENTS WERE NOT RETURNED WITH THE DEVICE. BASED ON 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 ASSOCIATED NONCONFORMING MATERIAL REPORTS OR EXCEPTIONS 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 AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. HEMOSTASIS WAS ACHIEVED BY APPLYING MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249602 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30722K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, ASPIRIN, PLAVIX