BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II BALLOON CATHETER

    MDR report key: 1170543 · Received September 11, 2008

    Report

    Report Number
    1319211-2008-00039
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 22, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVAL. WITHOUT THE ACTUAL COMPLAINT SAMPLE, ANGIODYNAMICS IS UNABLE TO CONDUCT A THOROUGH INVESTIGATION. THE EXACT CAUSE OF THE COMPLAINT IS UNK. IT WAS REPORTED THE INCIDENT OCCURRED 2 MONTHS BEFORE THE ACTUAL REPORT DATE, AND DETAILS OF THE INCIDENT WERE NOT CLEAR. A REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT INDICATED THAT ALL OF THE DEVICE SPEC AND QUALITY REQUIREMENTS WERE SATISFIED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING TO HELP PREVENT THIS TYPE OF COMPLAINT: "PROPER FUNCTIONING OF THE CATHETER DEPENDS ON ITS INTEGRITY. CARE SHOULD BE USED WHEN HANDLING THE CATHETER. DAMAGE MAY RESULT FROM KINKING, STRETCHING, OR FORCEFUL WIPING OF THE CATHETER." "IF RESISTANCE IS FELT UPON REMOVAL, THEN THE BALLOON, GUIDEWIRE, AND THE SHEATH SHOULD BE REMOVED TOGETHER AS A UNIT, PARTICULARLY IF BALLOON RUPTURE IS KNOWN OR SUSPECTED. THIS MAY BE ACCOMPLISHED BY FIRMLY GRASPING THE BALLOON CATHETER AND SHEATH AS A UNIT AND WITHDRAWING BOTH TOGETHER, USING A GENTILE TWISTING MOTION COMBINED WITH TRACTION." THIS CATHETER IS NOT IDENTIFIED FOR THE EXPANSION OR DELIVERY OF STENTS. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME. FREQUENCY HAS INCREASED, BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY PROCEDURE, THE DISTAL BOND OF THE BALLOON WAS COMPROMISED, RESULTING IN BALLOON FAILURE. THE BALLOON DID NOT COMPLETELY SEPARATE FROM THE SHAFT, AND APPARENTLY THE BALLOON WAS RETRIEVED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II BALLOON CATHETER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY LIT ANGIODYNAMICS, INC. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention