BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION)

    MDR report key: 1053398 · Received May 27, 2008

    Report

    Report Number
    2024168-2008-00426
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND DETERMINED THAT FACTORS THAT MAY CONTRIBUTE TO BALLOON DAMAGE MAY INCLUDE, BUT NOT LIMITED TO, MANUFACTURING, MATERIALS, PATIENT ANATOMY, PATIENT DISEASE STATE, ASSOCIATIVE DEVICE INTERACTION, LESION TORTUOSITY, OVER INFLATION, OR INSUFFICIENT PREPARATION PRIOR TO USE. THE PATIENT ANATOMY WAS DESCRIBED AS MILD TORTUOUS AND CONCENTRIC, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. HOWEVER, WITHOUT THE DEVICE TO EXAMINE, A THOROUGH ANALYSIS COULD NOT BE PERFORMED AND NO DETERMINATION CAN BE MADE AS TO THE ROOT CAUSE OF THE REPORTED BALLOON RUPTURE.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT AN IN-STENT RESTENOSIS (ISR) OF A PREVIOUSLY DEPLOYED STENT WAS NOTED. THE ESPRIT BALLOON WAS ADVANCED TO THE ISR AND WAS INFLATED. THE PRESSURE WAS INCREASED FROM 6 ATM TO 8ATM AND THE BALLOON RUPTURED. ANOTHER COMPANY'S BALLOON CATHETER WAS USED TO DILATE THE ISR. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. NO ADD'L EVENT OR PATIENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION) LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 6090551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE CATH: HEARTRAIL JL4.6FR| GUIDE WIRE: PILOT 50| DIL CATH: QUANTUM 3.0 X 20