BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2120585 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04122
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. ESTIMATE AGE(PATIENT WAS REPORTED TO BE HIS (B)(6)). THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW IF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED INCIDENT. A SUTURE BREAK CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO MANUFACTURING, TOO MUCH TENSION APPLIED, OR THE SUTURE WAS NICKED. WHETHER THESE CONDITIONS PLAYED A ROLE IN THE EXPERIENCED EVENT CANNOT BE VERIFIED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS A SAMPLING OF SUTURES ARE TESTED UNDER STRESS FOR DIAMETER MEASUREMENTS BEFORE RELEASE TO MANUFACTURING. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. IT SHOULD BE NOTED THAT THE APPLICATION OF EXCESS FORCE TO THE WHITE SUTURE IS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU) WHICH INSTRUCTS THE USER TO GENTLY PULL THE NON-RAIL (WHITE) SUTURE LIMB. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHILE ADVANCING THE KNOT AND PULLING ON THE WHITE SUTURE, EXCESS FORCE WAS APPLIED AND THE SUTURE BROKE. MANUAL COMPRESSION, APPLIED FOR 15 MINUTES AND A NON- ABBOTT DEVICE WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 040286H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention