BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    MDR report key: 1230398 · Received November 7, 2008

    Report

    Report Number
    3004742046-2008-00270
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. DEVICE #1 STARCLOSE, PART# 14677-01, LOT# UNK, IS BEING FILED UNDER MEDWATCH MANUFACTURER REPORT NUMBER: 2953144-2008-01792. DEVICE #3 AGILTRAC, PART# 1010065-20, LOT# UNK, IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A WEEK LATER, CLAUDICATION OF THE RIGHT LEG DEVELOPED. A DUPLEX ULTRASOUND SUGGESTED A HIGH-GRADE STENOSIS. AN ANGIOGRAM REVEALED THAT DESPITE THE CLIP HAVING BEEN DEPLOYED IN AN APPROPRIATE FASHION, IT CAUSED A SIGNIFICANT DEGREE OF STENOSIS AT THE FEMORAL ARTERY SITE. CRYOPLASTY AND ANGIOPLASTY WERE PERFORMED. DURING ANGIOPLASTY TWO AGILTRAC DILATATION BALLOONS WERE USED; BOTH RUPTURED AT AN UNSPECIFIED PRESSURE. THE BALLOONS WERE REMOVED FROM THE BODY WITHOUT ANY RESIDUAL MATERIAL REMAINING. DISTAL ANGIOGRAMS CONFIRMED REESTABLISHED FLOW TO THE RIGHT LEG WITH PALPABLE PULSES BEING DOCUMENTED. THERE WERE NO REPORTED PATIENT SEQUELAE. 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 DEVICE #3 AGILTRAC| DEVICE #1 STARCLOSE