BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3873047 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03829
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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-CONFORMING MATERIAL REPORTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. TWELVE (12) UNUSED, STERILE REPRESENTATIVE SAMPLES WERE RETURNED FOR PROGLIDE (PART NUMBER 12673-05). TWO (2) WITH LOT NUMBER 40203K1, AND EIGHT (8) WITH LOT NUMBER 40310K1 AND TWO (2) WITH LOT NUMBER 40227K1. BASED ON A VISUAL AND FUNCTIONAL INSPECTION ANALYSIS OF THE RETURNED DEVICES, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORDS REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HISTORY OF THE RETURNED LOTS DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4): FAILURE TO FOLLOW STEPS. A FEMORAL ANGIOGRAM WAS NOT TAKEN. PER THE INSTRUCTIONS FOR USE - PERFORM A FEMORAL ANGIOGRAM THROUGH THE INTRODUCER SHEATH TO VERIFY THAT THE ACCESS SITE IS IN THE COMMON FEMORAL ARTERY. TO AVOID POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY, FLUOROSCOPICALLY EVALUATE THE FEMORAL ARTERY FOR SIZE, CALCIUM TORTUOSITY, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL. THE DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL PROCEDURE, ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, AFTER THE PLUNGER WAS RETRACTED AND DURING SUTURE RETRIEVAL, THE BLUE RAIL SUTURE LIMB DID NOT APPEAR. A SECOND PROGLIDE DEVICE WAS USED, BUT DURING SUTURE RETRIEVAL THE WHITE RAIL SUTURE LIMB DID NOT APPEAR. HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO FEMORAL ANGIOGRAM WAS TAKEN. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349239 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40203K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, PLAVIX AND ASA (ASPIRIN)