BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4190495 · Received October 21, 2014

    Report

    Report Number
    2024168-2014-06869
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS, HOWEVER, BECAUSE THE PLUNGER, SUTURE, LINK, NEEDLES AND CUFFS WERE NOT RETURNED, THE REPORTED CUFF MISS COULD NOT BE CONFIRMED. BASED ON A VISUAL INSPECTION AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IT WAS REPORTED THAT A VENOUS SHEATH WAS NEXT TO THE ARTERIAL SHEATH. THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE. THE OTHER THREE PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, VIA A 8F SHEATH PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THERE WAS A VENOUS SHEATH NEXT TO THE ARTERIAL SHEATH DURING CLOSING. REPORTEDLY, THE FIRST DEVICE WAS DEFECTIVE. THREE ADDITIONAL PROGLIDE DEVICES WERE USED AND CUFF MISSES OCCURRED WITH ALL THREE DEVICES. THE SUTURES OF TWO ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO 21F AND THE AAA PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED USING THE SUCCESSFULLY PRE-PLACED SUTURES OF THE FIFTH AND SIXTH PROGLIDE DEVICES. 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
    668073 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40623K1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SHEATH: 8F, 21F, HEPARIN