BEUDAMED
    FDA Adverse Event Death Summary report: N

    WORKHORSE II BALLOON CATHETER

    MDR report key: 1719911 · Received April 29, 2010

    Report

    Report Number
    1319211-2010-00018
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    October 15, 2009
    Report Date
    April 28, 2010
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE REPORTED COMPLAINT IS INCONCLUSIVE. THE INFO PROVIDED IS VERY LIMITED. A SHIP HISTORY WAS CONDUCTED AND SHOWS THE REPORTED FACILITY DID NOT PURCHASE ANY BALLOON CATHETERS BETWEEN (B) (6) 2006-(B) (6) 2009. THE CAUSE OF THE COMPLAINT IS UNK. IT IS POSSIBLE THE BALLOON RUPTURE OCCURRED DUE TO OVER INFLATION. 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." 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. DO NOT ADVANCE THE GUIDEWIRE, BALLOON DILATION CATHETER OR ANY OTHER COMPONENT IF RESISTANCE IS MET, WITHOUT FIRST DETERMINING THE CAUSE AND TAKING REMEDIAL ACTION. 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 GENTLE TWISTING MOTION COMBINED WITH TRACTION. BEFORE REMOVING CATHETER FROM SHEATH IT IS VERY IMPORTANT THAT THE BALLOON IS COMPLETELY DEFLATED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE FACILITY. THIS COMPLAINT WILL BE RE-OPENED IF ADDITIONAL INFO IS PROVIDED. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    WHILE UNDERGOING LOWER EXTREMITY ANGIOGRAM WITH BALLOON ANGIOPLASTY, THE CATHETER BALLOON RUPTURED IN A FEMORAL ARTERY. THE RETAINED BALLOON WAS RETRIEVED BY OPEN EXPOSURE OF THE ARTERY; LATER THAT DAY SHE REQUIRED EMERGENT FEMORAL ENDARTERECTOMY AND PATCH BYPASS TO TREAT PROFOUND ISCHEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R