BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILER BALLOON CATHETER

    MDR report key: 1021945 · Received March 28, 2008

    Report

    Report Number
    1319211-2008-00009
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LOX
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE CATALOG NUMBER AND LOT NUMBER WERE NOT PROVIDED. A SHIP HISTORY WAS CONDUCTED ON THE REPORTED DESCRIPTION. THE SHIP HISTORY SHOWED THE CATALOG NUMBER AS BEING 16801129. THE FOLLOWING LOTS OF 168001129 WERE SHIPPED TO THE COMPLAINANT IN THE LAST YEAR: 935405, 931971, 928437 AND 928436. THE POSSIBLE LOT HISTORY RECORDS WERE REVIEWED FOR ANY ABNORMALITIES, WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING WAS FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION. CONCLUSION: THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, ANGIODYNAMICS IS UNABLE TO CONDUCT A THOROUGH INVESTIGATION. THE CAUSE OF THE COMPLAINT IS UNKNOWN. IT IS POSSIBLE THE BALLOON WAS NOT COMPLETELY DEFLATED BEFORE IT WAS PULLED THROUGH THE SHEATH. A REVIEW OF THE MFG RECORDS FOR THE POSSIBLE LOTS INDICATED THAT ALL OF THE DEVICE SPECIFICATION AND QUALITY REQUIREMENTS WERE SATISFIED. THE INSTRUCTIONS FOR USE STATES: CAUTION: DO NOT EXCEED THE RATED BURST PRESSURE. A SYRINGE WITH PRESSURE GAUGE IS RECOMMENDED TO MONITOR PRESSURE. PRESSURE IN EXCESS OF THE RATED BURST PRESSURE CAN CAUSE BALLOON RUPTURE AND POTENTIAL INABILITY TO WITHDRAW THE CATHETER THROUGH THE INTRODUCER SHEATH. IF RESISTANCE IS FELT UPON REMOVAL, THEN THE BALLOON, GUIDEWIRE AND THE SHEATH SHOULD BE REMOVED TOGETHER AS A UNIT, PARTICULARLY IF BALLOON RUPTURE OR LEAKAGE 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 GENTLY TWISTING MOTION COMBINED WITH TRACTION. BEFORE REMOVING CATHETER FROM SHEATH, IT IS VERY IMPORTANT THE BALLOON IS COMPLETELY DEFLATED. 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. PLEASE CHECK THE PACKAGE LABEL FOR THE RATED BURST PRESSURE. IT IS IMPORTANT THAT THE BALLOON NOT BE INFLATED BEYOND THE RATED BURST PRESSURE. LABELING: IS RATED FOR 16ATM, 5F SHEATH. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    6MM WAS STUCK INSIDE A 5F TERUMO SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILER BALLOON CATHETER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY LOX ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1