BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3132894 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03307
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    March 26, 2013
    Report Date
    May 9, 2013
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT, SUTURE WOULD NOT TAKE DURING ATTEMPTED SUTURE PLACEMENT, WAS NOT CONFIRMED. THE ANALYSIS OF THE RETURNED DEVICE INDICATES THAT DEPLOYMENT OF THE PLUNGER, DID NOT OCCUR BECAUSE THE PLUNGER WAS STILL INSIDE THE DEVICE. BASED ON THE 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE WAS SUCCESSFUL WITH THE FIRST PROGLIDE DEVICE. REPORTEDLY, WHILE USING A SECOND PROGLIDE DEVICE, THE SUTURE "WOULD NOT TAKE" DURING ATTEMPTED SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE. A THIRD PROGLIDE DEVICE WAS USED FOR SUCCESSFUL SUTURE PLACEMENT PRIOR TO THE AAA PROCEDURE. THE ARTERIOTOMY WAS 6F AND WAS UPSIZED TO 21F FOR THE AAA PROCEDURE. THE AAA PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED USING THE SUCCESSFULLY PLACED PROGLIDE SUTURES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN REPORTEDLY 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
    234571 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30221K1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention SHEATH: 6F, 21F HEPARIN