BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 2071465 · Received April 28, 2011

    Report

    Report Number
    9616099-2011-00282
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 31, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K071189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE CATHETER AVIATOR PLUS 4.0MM X 30 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THERE WERE TIP RIPPED. THERE WERE CRYSTALLIZED CONTRAST MEDIUMS ON THE CATHETER. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED. BALLOON DID NOT PRESENT BURST CONDITION. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. THE BALLOON WAS INFLATED AND NOT LEAK WAS NOTED A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE PTA SYSTEM SEPARATED PRIOR TO USE BY THE COSTUMER WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE DISTAL TIP DAMAGED FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS, CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE TIPS FROM LEAVING THE FACILITY (CONTROL REFERENCE E.G. MANUFACTURING WORK INSTRUCTION (B)(4)) , NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ALTHOUGH THE ACCOUNT CLAIMED THAT THE SEPARATED TIP WAS NOTICED PRIOR TO USE ON THE PATIENT AND THAT THE DEVICE WAS NOT USED IN THE PATIENT THE RETURNED PRODUCT SHOWED EVIDENCE OTHERWISE. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DOING A CASE IN WHICH HE WAS GOING TO USE A 4.0 X 30 X 142 AVIATOR BALLOON. BEFORE USING IT ON THE PATIENT, THEY NOTICED SOMETHING ON THE WIRE, AND IT WAS THE BALLOON THAT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15228712

    Patients

    Seq Age Sex Outcome Treatment
    1