BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3913424 · Received July 3, 2014

    Report

    Report Number
    2024168-2014-04354
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. HOWEVER, SIX, UNUSED, STERILE PROGLIDE DEVICES WITH THE SAME PART AND LOT NUMBER, 40325K1, AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED STERILE DEVICES, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMING MATERIAL REPORTS OR EXCEPTIONS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 OTHER PERCLOSE PROGLIDE DEVICE REFERENCED FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED WITH TWO PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE WITH A 6F SHEATH, PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS REMOVED, NO NEEDLES WERE ATTACHED TO THE PLUNGER. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. THE AAA PROCEDURE WAS COMPLETED. A CUT DOWN WAS PERFORMED AND THE ARTERY WAS SURGICALLY CLOSED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390930 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40325K1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SHEATH: 6F