BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST INFLATION DEVICE 30ATM

    MDR report key: 2861997 · Received December 7, 2012

    Report

    Report Number
    1220452-2012-00066
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 31, 2012
    Report Date
    March 12, 2013
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DTL
    PMA / PMN Number
    K960983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS CURRENTLY BEING PERFORMED ON THE RETURNED DEVICE. ONCE THE EVALUATION IS COMPLETED A FOLLOW- UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED DURING THE CASE WAS EVALUATED. VISUAL EXAMINATION OF THE RETURNED INFLATION DEVICE REVEALED THAT THERE IS RESIDULE FLUID IN THE EXTENSION LINE AND BARREL OF THE DEVICE. THE MANOMETER NEEDLE IS RESTING ON ZERO. THERE DOES NOT APPEAR TO BE ANY DAMAGE ON THE DEVICE. AN INFLATION TEST WAS PERFORMED AND THE NEEDLE OF THE MANOMETER MOVED ERRATICALLY FROM ZERO. VACUUM TESTING WAS CONDUCTED AND THE NEEDLE OF THE MANOMETER BECAME STUCK ON 9ATM. THE DEVICE WAS SHIPPED TO THE CONTRACT MANUFACTURER FOR EVALUATION. A PRESSURE TEST WAS CONDUCTED AND THE NEEDLE OF THE MANOMETER STOPPED AT 3ATM. THE MANOMETER WAS DISASSEMBLED AND INSPECTED UNDER MAGNIFICATION. AN UNKNOWN SUBSTANCE WAS NOTICED IN THE FILTER AREA. THE TESTING OF THIS SUBSTANCE INDICATES THAT IT IS CONTRAST MEDIA. THE CONTRAST MEDIA CRYSTALLIZED OR REACTED WITH THE FILTER AND CLOGGED THE PASSAGE WAY PREVENTING PROPER OPERATION OF THE MANOMETER. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES WITHIN THE MANUFACTURING PROCESS. THE EVENT IS NOT CONFIRMED FOR DEFECTIVE MANOMETER. CONTRAST MEDIA CRYSTALLIZED AND REACTED WITH THE FILTER AND CLOGGED THE PASSAGE WAY PREVENTING PROPER OPERATION OF THE GAUGE. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4) 2013.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: INFLATION DEVICE WAS USED FOR PCI WITH STENT. DURING INFLATION IT WAS REPORTED, THE MANOMETER DID NOT MOVE UPPER THAN CERTAIN PRESSURE. THE PHYSICIAN WAS PRESSURIZING CONTINUOUSLY, THE DELIVERY BALLOON WAS THEN RUPTURED AND THE STENT WAS EXPANDED EXCESSIVELY. NO DAMAGE WAS NOTED ON THE PACKAGE. PREPARATION WAS PERFORMED AND NO ABNORMALITY NOTED. THE MANOMETER STOPPED AT AROUND 12ATM. PRESSURE APPLIED FOR 20SEC AT 12ATM. THE PRESSURE WHEN THE STENT DELIVERY BALLOON WAS RUPTURED IS UNKNOWN (NOT RECORDED). AFTER BALLOON RUPTURE THE DEVICE WAS WITHDRAWN FROM THE PATIENT SAFELY. NO HEALTH HAZARD TO THE PATIENT. CINE IMAGES ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVEREST INFLATION DEVICE 30ATM ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS DTL MEDTORNIC, INC 50673664

    Patients

    Seq Age Sex Outcome Treatment
    1