BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2925195 · Received January 22, 2013

    Report

    Report Number
    2024168-2013-00360
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE (B)(4): 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 TWO PERCLOSE PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    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 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 RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE BEFORE AN INTERVENTIONAL PROCEDURE. THE ARTERIOTOMY WAS A 7FR AND DURING THE INTERVENTIONAL PROCEDURE THE SHEATH WAS UPSIZED TO AN 20FR SHEATH. REPORTEDLY, TWO PROGLIDES WERE SUCCESSFULLY DEPLOYED; HOWEVER, OOZING CONTINUED AFTER FINISHING THE PROCEDURE. A THIRD PROGLIDE WAS DEPLOYED AND NO SUTURES WERE PRESENT UPON PLUNGER REMOVAL. A FOURTH PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED 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
    30890 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21105J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7FR, 20FRHEPARIN