BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2040178 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02368
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 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
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION. THE FIRST PROGLIDE IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE INDICATED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES DURING NEEDLE DEPLOYMENT. DURING THE NEEDLE PLUNGER RETRACTION, THE LINK BROKE AT THE SWAGE END OF THE POSTERIOR CUFF. SUBSEQUENTLY, THE SUTURE KNOT BECAME UNRAVELED AND THE SUTURE COULD NOT BE RETRIEVED; THEREFORE, THERE WOULD NOT BE A KNOT TO ADVANCE TO THE ARTERIAL SURFACE AS REPORTED. THE LINK BREAK WHILE RETRACTING THE NEEDLE PLUNGER INDICATED THAT THERE WAS RESISTANCE ENCOUNTERED DURING THE NEEDLE PLUNGER REMOVAL PROCESS. DURING TESTING, THE PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. IN ADDITION, THERE WAS NO DAMAGE TO THE SUTURE TO SUGGEST THAT IT MIGHT HAVE BEEN DRAGGED THROUGH THE DEVICE DURING SUTURE RETRIEVAL PROCESS WHICH COULD POTENTIALLY CONTRIBUTE TO THE LINK BREAK. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. CHALLENGING ANATOMICAL CONDITIONS AND ABRUPTLY PULLING OUT THE NEEDLE PLUNGER COULD BE CONTRIBUTING FACTORS, BUT THIS COULD NOT BE CONFIRMED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER ADVANCING THE KNOT TO THE ARTERIAL SURFACE, BLEEDING CONTINUED. VESSEL ACCESS WAS MAINTAINED BY REINSERTING A GUIDE WIRE. THE SUTURE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT AFTER ADVANCING THIS KNOT TO THE ARTERIAL SURFACE, BLEEDING CONTINUED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 970026H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention