BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2230196 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06065
    Event Type
    Injury
    Date Received
    September 1, 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
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. NO PULSATILE BLOOD FLOW FROM THE MARKER LUMEN CAN BE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO MANUFACTURING, OPERATOR DEPLOYMENT TECHNIQUE, OR PATIENT ANATOMICAL CONDITIONS. POSSIBLE CAUSES FOR THE REPORTED EXPERIENCE IS THE MARKER PORT OF THE DEVICE NOT BEING IN THE ARTERIAL LUMEN, OR THE MARKER PORT BEING PLACED AGAINST THE PATIENT ARTERY MAY CAUSE A SLOW OR NO BLOOD FLOW THROUGH THE MARKER LUMEN. HOWEVER, NO INFORMATION ABOUT USER TECHNIQUE WAS PROVIDED. PATIENT ANATOMICAL CONDITIONS SUCH AS LOW BLOOD PRESSURE, A BLOOD CLOT, SMALL PATIENT VESSEL DIAMETER, OR TISSUE INTERFERENCE MAY CAUSE NO PULSATILE BLOOD FLOW FROM THE MARKER LUMEN. IN THIS CASE, IT WAS REPORTED THAT THE COMMON FEMORAL ARTERY WAS MILDLY CALCIFIED, WHICH MAY HAVE PLAYED A ROLE IN THE REPORTED EXPERIENCE. A CONCLUSIVE CAUSE FOR THE REPORTED ABSENT PULSATILE BLOOD FLOW FROM THE DEVICE MARKER LUMEN THAT RESULTED IN CONTINUED BLEEDING WILL REQUIRE AN ALTERNATIVE METHOD TO ACHIEVE HEMOSTASIS. PULSATILE FLOW FROM THE MARKER LUMEN OF EACH DEVICE IS TESTED DURING MANUFACTURING. IN ADDITION, SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED, TO INCLUDE PULSATILE FLOW FROM THE MARKER LUMEN, TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NON CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    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. A REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ALTHOUGH THE PROGLIDE DEVICE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS, THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE, THE DEVICE WAS DEPLOYED IN A CALCIFIED VESSEL. DURING DEVICE INSERTION, CALCIFICATION CAN BREAK OFF AND OCCLUDE THE MARKER PORT OR LUMEN CAUSING FAILURE TO ACHIEVE ARTERIAL LUMINAL MARKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERIPHERAL BELOW-THE-KNEE STENTING PROCEDURE, ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE PERCLOSE PROGLIDE DEVICE. REPORTEDLY, DURING POSITIONING OF THE DEVICE, PULSATILE BLOOD FLOW WAS ABSENT FROM THE DEVICE MARKER LUMEN TO INDICATE ARTERIAL MARKING. THE DEVICE WAS PULLED BACK AND REPOSITIONED, BUT NO PULSATILE BLOOD FLOW THROUGH THE MARKER LUMEN CONTINUED. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN WAS REPORTED TO BE TRAINED USE OF THE PERCLOSE 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 020196H

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention HEPARIN, ASPIRIN