BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3111421 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03025
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ESTIMATED DATE OF OCCURRENCE, EXACT DATE WAS NOT SPECIFIED. IT WAS REPORTED THAT THE RIGHT COMMON FEMORAL ARTERY WAS MILDLY CALCIFIED. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER THREE PROGLIDE DEVICES REFERENCED 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 SUTURE PLACEMENT WAS ATTEMPTED USING TWO PROGLIDE DEVICES IN THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, AFTER NEEDLE DEPLOYMENT, NO SUTURE WAS ATTACHED TO THE NEEDLES. THE TWO PROGLIDE DEVICES WERE REMOVED AND SUTURE PLACEMENT USING TWO ADDITIONAL PROGLIDE DEVICES WAS ATTEMPTED. AFTER NEEDLE DEPLOYMENT AND WHEN THE NEEDLE PLUNGER WAS RETRACTED ON BOTH THE PROGLIDE DEVICES, THE SUTURES BROKE. THE TWO ADDITIONAL PROGLIDE DEVICES WERE REMOVED. ANOTHER TWO PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS A 6F AND THE SHEATH WAS UPSIZED TO AN 18F TO PERFORM THE TAVI PROCEDURE. HEMOSTASIS WAS ACHIEVED USING THE THIRD SET OF TWO PRE-PLACED PROGLIDE SUTURES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212075 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30223K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 18F HEPARIN