BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2233536 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06136
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A THOROUGH ANALYSIS COULD NOT BE PERFORMED ON THE PRODUCT BECAUSE IT WAS NOT RETURNED TO ABBOTT VASCULAR FOR INVESTIGATION. THE REPORT OF SUTURE NOT HAVING A KNOT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, PATIENT'S ANATOMICAL CONDITION AND/OR USER TECHNIQUE. IF THE PLUNGER IS PULLED BACK TOO QUICKLY THE KNOT MAY UNRAVEL, OR IF THE OPERATOR PULLS THE SUTURE LOOP (LOCATED AT DISTAL END OF GUIDE) INSTEAD OF BOTH SUTURE ENDS WHEN REMOVING THE DEVICE FROM THE PATIENT, OR IF THE LEVER IS CLOSED PRIOR TO HARVESTING THE SUTURE, THE KNOT MAY UNRAVEL GIVING THE IMPRESSION THAT THE SUTURE DID NOT HAVE A KNOT. DEPLOYING THE DEVICE IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) MAY INTERFERE WITH HARVESTING OF THE SUTURE AND CAUSE THE KNOT TO UNRAVEL. A CONCLUSIVE CAUSE FOR THE REPORTED SUTURE NOT HAVING A KNOT COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER INCIDENTS REPORTED FOR THE SUTURE NOT HAVING A KNOT. BASED ON THE REVIEW OF THE LOT HISTORY RECORD, THE COMPLAINT HANDLING DATABASE, EVENT INFORMATION AND MANUFACTURING TESTING/INSPECTION CRITERIA FOR THIS LOT, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED. DURING MANUFACTURING, ALL DEVICES ARE VISUALLY INSPECTED AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE, INCLUDING THE PLACEMENT OF THE KNOT IN A TISSUE MODEL.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED PLACEMENT OF TWO PROGLIDE DEVICES IN A PRE-CLOSURE FASHION PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE IN A NON-CALCIFIED RIGHT COMMON FEMORAL ARTERY. REPORTEDLY, BOTH PROGLIDE DEVICES WERE DEPLOYED UNEVENTFULLY, THE INDEX PROCEDURE WAS COMPLETED AND WHEN THE KNOTS WERE BEING TIED TO CLOSE THE ARTERIOTOMY, IT WAS FELT THAT THE SUTURES OF ONE OF THE PROGLIDE DEVICES DID NOT HAVE A KNOT, THE PHYSICIAN COULD PULL ON THE SUTURES WITHOUT ANY RESISTANCE. THE SURGEON THAT WAS PRESENT DURING THE CASE MADE A KNOT HIMSELF WITH THE SUTURES, AN ADDITIONAL PROGLIDE WAS ALSO DEPLOYED AND ALL THE SUTURES WERE USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT IS PART OF THE ENDOLOGIX PEVAR CLINICAL TRIAL. A 6FR SHEATH WAS USED DURING CLOSURE DEVICE PLACEMENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 910266H

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention SHEATH: 6 FR, 9 FR.| HEPARIN.