BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7534357 · Received May 22, 2018

    Report

    Report Number
    2024168-2018-03808
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    April 13, 2018
    Report Date
    July 3, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: LOT NUMBER WAS CHANGED FROM 7071441 TO 8012541. EVALUATION SUMMARY: ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE DETACHMENT WAS CONFIRMED. THE REPORTED DIFFICULTY REMOVING THE PLUNGER WAS NOT CONFIRMED AS THE RETURNED PLUNGER WAS RE-INSERTED IN THE DEVICE AND RETRACTED WITHOUT RESISTANCE NOTED. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO INTERACTION WITH THE PATIENT CALCIFICATION AND SUBSEQUENT 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) INTERVENTIONAL PROCEDURE. REPORTEDLY, THERE WAS RESISTANCE RETRACTING THE NEEDLE PLUNGER AFTER DEPLOYMENT AND WHILE PULLING THE SUTURE, IT EITHER BROKE OR WAS "LOST". THE DEVICE WAS REMOVED AND THE SUTURES OF TWO NEW PROGLIDE DEVICE WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 16F AND THE TAVI PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES. THERE WAS NO REPORTED 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
    374016 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 8012541

    Patients

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