BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7778852 · Received August 13, 2018

    Report

    Report Number
    2024168-2018-06222
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    June 26, 2018
    Report Date
    August 22, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: LOT NUMBER UPDATED FROM 8040642 TO 8032341. EVALUATION SUMMARY: VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY RETRACTING THE PLUNGER COULD NOT BE TESTED AS THE PLUNGER WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUNCTURE CLOSURE OF A AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE PROGLIDE PLUNGER DID NOT FUNCTION PROPERLY. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT REPORTED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619440 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 8032341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention