BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIIA PTA BALLOON CATHETER

    MDR report key: 929656 · Received October 18, 2007

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    Report

    Report Number
    9610978-2007-00382
    Event Type
    Malfunction
    Date Received
    October 18, 2007
    Date of Event
    October 2, 2007
    Report Date
    October 2, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K050645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY AND REVIEW CONFIRMED THAT SUBASSEMBLIES ALSO MET ALL REQUIREMENTS PER THE APPLIABLE MQP AS WELL. THIS PRODUCT WILL BE RETURN FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO LEFT SUBCLAVIAN ARTERY, THERE WAS WITHDRAWAL DIFFICULTY THROUGH THE SHEATH WITH THE BALLOON CATHETER. THE CATHETER WAS NORMAL IN APPEARANCE AS IT CAME FROM THE PACKAGING. THE PRODUCT WAS PREPPED AND USED FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE VESSEL WAS NEITHER CALCIFIED NOR TORTUOUS, HOWEVER, IT WAS 100% STENOTIC. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED RESULTING IN RESIDUAL 50% STENOSIS. THEREAFTER, THE REPORTED DEVICE WAS INTRODUCED AND POBA WAS CONDUCTED AGAIN. THE BALLOON WAS INFLATED TWICE WITH AN INDEFLATOR AT 10ATMOSPHERES. THE BALLOON WAS DEFLATED WITHOUT DIFFICULTIES AND WAS COMPLETELY REWRAPPED. THEN ATTEMPTS WERE MADE TO WITHDRAWAL BALLOON CATHETER FROM THE VESSEL, HOWEVER, IT WAS STUCK AT THE DISTAL TIP OF THE SHEATH INTRODUCER. THEREFORE, THE BALLOON AND THE SHEATH WERE RETRIEVED AS ONE UNIT FORCIBLY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIIA PTA BALLOON CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0406216

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR GUIDEWIRE DEJAVU/ASAHI INTECC| INDEFLATOR/EDGE MEDICAL| SHEATH INTRODUCER 4FR/TERUMO