BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 997669 · Received February 11, 2008

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    Report

    Report Number
    9610978-2008-00050
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    January 17, 2007
    Report Date
    January 18, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PROD HAS BEEN RETURNED FOR EVAL AND TESTING, HOWEVER THE FAILURE ANALYSIS REPORT IS NOT YET COMPLETE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER 11137851 WITH LOT NUMBER 0305070115. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING THE BURST TEST VALUES. ADD'L INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED A CIRCUMFERENTIAL BALLOON BURST OCCURRING DURING INFLATION AND CONSEQUENTLY THERE WAS WITHDRAWAL DIFFICULTY THROUGH THE GUIDING CATHETER. THE INTEND PROCEDURE WAS TREATMENT OF THE LEFT RENAL ARTERY. A GUIDEWIRE WAS INSERTED WITHOUT DIFFICULTY AND AN INTERNAL MAMMARY (IM) GUIDING CATHETER WAS USED. THE AVIATOR PLUS PTA DILATATION CATHETER WAS INSERTED, LESION REACHED AND PREDILATED HOWEVER THE BALLOON BURST AT 12 ATM WITH A CIRCUMFERENTIAL TEAR. AN ATTEMPT TO RETRIEVE THE PTA SYS WAS MADE THROUGH THE GUIDING CATHETER HOWEVER THE PTA SYS WOULD NOT COME OUT OF THE GUIDING CATHETER (BALLOON WAS ELONGATING). THEREFORE THE GUIDING CATHETER AND PTA SYS WERE REMOVED AS ONE UNIT WHILE LEAVING THE GUIDEWIRE IN THE PT. ANOTHER GUIDING CATHETER AND PTA BALLOON WERE USED TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT. OF NOTE: IS NOT CLEAR IF THE BALLOON SEPARATED WITHIN THE GUIDING CATHETER AND CLARIFICATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS LIT CORDIS EUROPA, N.V. NA R0607004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALL STAR 0.014 CORONARY GUIDE WIRE (ABBOTT)| INTERNAL MAMMARY (IM) GUIDING (50 CM LONG| CATHETER/ABBOTT)