BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2851316 · Received November 29, 2012

    Report

    Report Number
    2024168-2012-07547
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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. THE SIX ADDITIONAL PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    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. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE WAS ATTEMPTED WITH THE PROGLIDE DEVICE IN THE RIGHT COMMON FEMORAL ARTERY (RCFA) USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. THE RCFA WAS MODERATELY CALCIFIED. THERE WAS NO CALCIFICATION NOTED AT THE ACCESS SITE. THE ARTERIOTOMY WAS 6FR. REPORTEDLY, DEPLOYMENT OF THE PROGLIDE DEVICE WAS ATTEMPTED. WHEN THE PLUNGER WAS RETRACTED THERE WAS NO SUTURE ATTACHED TO THE NEEDLE. THE DEVICE WAS REMOVED AND 4 ADDITIONAL DEVICES WERE ATTEMPTED, ONE AT A TIME, WITH THE SAME RESULT. TWO ADDITIONAL PROGLIDES FROM A DIFFERENT LOT WERE DEPLOYED UNEVENTFULLY IN AN X PATTERN; HOWEVER, THERE WAS SUFFICIENT BLOOD LOSS AT THE PUNCTURE SITE DURING DEPLOYMENT OF THE TWO PROGLIDE DEVICES. THE SHEATH WAS UPSIZED TO 16FR TO PERFORM THE AAA PROCEDURE. AFTER COMPLETION OF THE INDEX PROCEDURE, HEMOSTASIS WAS NOT ACHIEVED WITH THE DEPLOYED PROGLIDE SUTURES AS BLEEDING WAS STILL OBSERVED AT THE PUNCTURE SITE. THE SUTURE CAME OUT WHILE TRYING TO SLIP THE SUTURE ONTO THE ARTERY. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. FIFTEEN MINUTES LATER A CUT DOWN PROCEDURE WAS PERFORMED AND AN OCCLUSION OF THE RCFA WAS OBSERVED. A PATCH WAS USED TO REPAIR THE VESSEL AND HEMOSTASIS WAS ACHIEVED SURGICALLY. THERE WAS SIGNIFICANT IMPACT TO THE PATIENT DUE TO A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OF 2 HOURS. AN UNSPECIFIED MEDICATION WAS GIVEN TO THE PATIENT DUE TO THE ISSUES WITH THE USE OF THE PROGLIDE DEVICES. THE PHYSICIAN BELIEVES THE 7 PROGLIDES CAUSED/CONTRIBUTED TO THE VESSEL OCCLUSION. THE EVENT RESULTED IN PROLONGED HOSPITALIZATION OF 24-48 HOURS. THE PHYSICIAN IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. 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 20830J1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R SHEATH: 16FR HEPARIN