BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2993162 · Received March 7, 2013

    Report

    Report Number
    2024168-2013-01324
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT WAS REPORTED THAT THE ARTERIOTOMY WAS 8F. THE PROSTAR XL 10F SYSTEM IS DESIGNED FOR USE IN CONJUNCTION WITH 8.5 TO 24F SHEATHS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. (B)(4). THE SECOND PROSTAR XL DEVICE REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROSTAR XL NEEDLES WERE REMOVED BUT THE SUTURE WAS NOT ABLE TO BE REMOVED DURING ATTEMPTED SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. THE ARTERIOTOMY WAS 8F. THE DEVICE WAS REMOVED AND A SECOND PROSTAR XL WAS USED. REPORTEDLY, THE NEEDLES OF THE SECOND PROSTAR XL WERE DEVIATED BY THE SUTURE OF THE FIRST PROSTAR XL. HEMOSTASIS WAS ACHIEVED BY PLACING A GRAFT STENT FROM AN ACCESS SITE IN THE LEFT COMMON FEMORAL ARTERY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE PROSTAR XL DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98202 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8FHEPARIN