BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 4MM X 4CM, 136CM

    MDR report key: 5310028 · Received September 20, 2004

    Report

    Report Number
    9610978-2004-01014
    Event Type
    Malfunction
    Date Received
    September 20, 2004
    Date of Event
    August 30, 2004
    Report Date
    September 20, 2004
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FROM THE AFFILIATE INDICATED THAT: THE PT WAS UNDERGOING A PROCEDURE ON A LESION IN THE TORTUOUS EXTERNAL ILIAC ARTERY. THE LESION WAS ABOUT 3CM LONG, AND HEAVILY CALCIFIED WITH MORE THAN (B)(6) STENOSIS. A 4CMX4MM POWER FLEX BALLOON WAS INTRODUCED TO PREDILATED THE SITE; IT WAS RUPTURED AT 6-8ATM. THE PREDILATION WAS SUCCESSFULLY COMPLETED WITH A SYNERGY 4MM4CM, BSJ. A WALL STENT, 8MM4CM, BSJ, WAS IMPLANTED IN THE ARTERY. A 6MM X 4CM POWER FLEX BALLOON WAS USED FOR POST DILATION, AND A PINHOLE RUPTURE WAS DETECTED. THE PHYSICIAN THOUGHT THAT IT MIGHT HAVE BEEN CAUGHT ON THE EDGE OF THE STENT. THE BALLOON WAS REMOVED AND THE POST DILATION WAS FINISHED WITH SYNERGY 6MMX4CM, BSJ. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PT INJURY. THIS IS THE SECOND OF 2 PRODUCTS USED DURING THE PROCEDURE OR INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT # 9610978-2004-01013. THE PRODUCTS ARE NOT AVAILABLE FOR EVAL AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    BALLOON RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 4MM X 4CM, 136CM PTA CATHETERS LIT CORDIS EUROPA, N.V. NA R0203952

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR