BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION)

    MDR report key: 1214115 · Received October 24, 2008

    Report

    Report Number
    2024168-2008-01013
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    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. FACTORS THAT CONTRIBUTE TO BALLOON RUPTURE INCLUDE BALLOON DAMAGE DURING MANUFACTURING, INTERACTION WITH OTHER DEVICES, EXCEEDING RATED BURST PRESSURE (RBP), PATIENT ANATOMY, LESION CALCIFICATION, OR LESION TORTUOSITY. THE LESION WAS MODERATELY TORTUOUS, MODERATELY CALCIFIED, AND 100% STENOSED, WHICH COULD HAVE CONTRIBUTED TO THE BALLOON RUPTURE. A REVIEW OF THE BALLOON RUPTURE TESTING FOR THIS LOT PERFORMED DURING RELIABILITY ENGINEERING SHOWED THE DATA EXCEEDED RBP. A THOROUGH ANALYSIS COULD NOT BE PERFORMED AND NO DETERMINATION CAN BE MADE AS TO THE ROOT CAUSE OF THE REPORTED DISCREPANCY.

    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 THE LESION TO BE TREATED WAS IN THE RCA, WITH MODERATE TORTUOSITY, MODERATE CALCIFICATION, AND A 100% STENOSIS. THIS WAS AN AMI CASE. THE LESION WAS PREDILATED WITH ANOTHER COMPANY'S BALLOON CATHETER. THEN, THE 3.5 X 20 MM ESPRIT BALLOON CATHETER WAS SELECTED FOR ADDITIONAL PREDILATION WHEN THE BALLOON RUPTURED. ANOTHER COMPANY'S BALLOON CATHETER WAS ALSO SELECTED, PREDILATION WAS PERFORMED AND ANOTHER COMPANY'S STENT WAS DEPLOYED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION) MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 6100351

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE CATH: MACH1 6F| WHISPER: MS| GUIDE WIRE: BMW HC| ESPRIT: 3.5-20| DIL CATH: LACROSSE 1.3-10| STENT: DRIVER 3.5-24| QUANTUM: 3.5-20