BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    MDR report key: 1137445 · Received August 25, 2008

    Report

    Report Number
    3004742046-2008-00201
    Event Type
    Malfunction
    Date Received
    August 25, 2008
    Date of Event
    July 7, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AGILTRAC .035 PERIPHERAL DILATATION CATHETER (PART 1010010-20, LOT 7012351) REFERENCED IS FILED UNDER MFR# 3004742046-2008-00200. EVALUATION SUMMARY: THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. REPORTEDLY THE LESION TREATED IN THIS INCIDENT WAS HEAVILY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO MECHANICAL DAMAGE TO THE BALLOON MATERIALS, SUCH THAT, IT RUPTURED UPON INFLATION. A PRE-EXISTING HOLE/ RUPTURE IN THE BALLOON WOULD LIKELY HAVE BEEN DETECTED DURING AN INSTRUCTIONS FOR USE DIRECTED PREP OR INSPECTION OF THE DEVICE. A DEFINITIVE ROOT CAUSE FOR THE BALLOON RUPTURE COULD NOT BE DETERMINED. ALL AGILTRAC BALLOONS ARE 100% INSPECTED FOR LEAKS AND 100% TESTED TO RATED BURST PRESSURE. THE LOT HISTORY RECORD REVIEW OF THIS LOT INDICATED THAT THE SAMPLES TESTED DURING RELIABILITY ENGINEERING ON-LINE EXCEEDED THE PRODUCT SPECIFICATION. REVIEW OF THE LOT HISTORY RECORD SHOWED NO NON-CONFORMITIES.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE HEAVILY CALCIFIED COMMON ILIAC ARTERY, TWO AGILTRAC DILATATION BALLOONS RUPTURED. THE FIRST BALLOON RUPTURED AT 10 ATMOSPHERES (ATM). THE SECOND BALLOON RUPTURED AT 8 ATM. BOTH DEVICES WERE COMPLETELY REMOVED FROM THE BODY UNEVENTFULLY. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .035 PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK AGILTRAC .035 PERIPHERAL DILATATION CATHETER| (PART 1010010-20