BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7127513 · Received December 18, 2017

    Report

    Report Number
    2024168-2017-09838
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 28, 2017
    Report Date
    January 26, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL PERCLOSE PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER - CHANGED FROM 7029641 TO 7092641. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUNCTURE CLOSURE OF AN UNSPECIFIED VESSSEL WAS ATTEMPTED USING TWO PROGLIDE DEVICES. REPORTEDLY, THE PROGLIDE DEVICES "BROKE" DURING USE. THE METHOD OF ACHIEVING HEMOSTASIS WAS NOT REPORTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE NAME OF THE PHYSICIAN WAS NOT PROVIDED; HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906395 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 7092641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention