BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 6201024 · Received December 22, 2016

    Report

    Report Number
    2024168-2016-09190
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 29, 2016
    Report Date
    March 6, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: LOT NUMBER CHANGED FROM 6090641 TO 6091241. EVALUATION SUMMARY: VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED LOSS OF ARTERIAL ACCESS WAS CONFIRMED AS A BILATERAL CUFF MISS WAS OBSERVED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CALCIFICATION AT THE ACCESS SITE AND THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 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.

    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 ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE AND PROSTAR XL DEVICES ARE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT REFERENCE NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WITH TWO PROGLIDE DEVICES AND ONE PROSTAR XL DEVICE WAS ATTEMPTED IN A HEAVILY CALCIFIED COMMON FEMORAL ARTERY (CFA) USING THE PRECLOSE TECHNIQUE PRIOR TO A AORTIC PROSTHESIS IMPLANT PROCEDURE. THE ARTERIOTOMY WAS 6FR. REPORTEDLY, WHEN THE PROGLIDE PLUNGER WAS REMOVED, THE SUTURE CAME OUT OF THE PATIENT ARTERY WITHOUT RESISTANCE AND NO KNOT. A SECOND PROGLIDE WAS ATTEMPTED; HOWEVER, WHEN THE PROGLIDE PLUNGER WAS REMOVED A SUTURE BREAK OCCURRED. A PROSTAR XL DEVICE WAS ATTEMPTED; HOWEVER, THE NEEDLES COULD NOT BE REMOVED. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE AND PROSTAR XL DEVICE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847923 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 6091241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FR