BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-PLAST XT PTA BALLOON DILATATION CATHETER

    MDR report key: 1130444 · Received August 14, 2008

    Report

    Report Number
    2020394-2008-00223
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K941706
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS MANUFACTURING LOT NUMBER. THE SAMPLE WAS RETURNED AND THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON BURST AND A PIECE DETACHED REMAINING IN THE PATIENTS BODY. THE PROCEDURE, A COMMON ILIAC ANGIOPLASTY WAS PERFORMED ON A PATIENT WITH HEAVILY CALCIFIED ARTERIES. THE CONSULTANT ENTERED THE LEFT SIDE COMMON FEMORAL ARTERY AND INFLATED THE BALLOON ONCE IN THE COMMON ILIAC AT THE ORIGIN AND THEN MOVED FURTHER DOWN THE EXTERNAL ILIAC, INFLATING THE BALLOON AGAIN. AT THIS POINT THE BALLOON BURST. WHILE PULLING BACK, ONLY NORMAL RESISTANCE FELT UNTIL THE DISTAL END OF THE BALLOON WAS AT THE END OF THE 6F SHAFT, THEN MET WITH GREATER RESISTANCE. THE BALLOON COULD NOT BE REMOVED THROUGH THE SHEATH, SO THE WHOLE UNIT WITH INTRODUCER REMOVED TOGETHER. IT WAS NOTED THAT THE INTERNAL CATHETER HAD STRETCHED TO ALMOST DOUBLE ITS LENGTH. THE DISTAL RADIOPAQUE MARKER WAS MISSING AND HALF OF THE ANGIOPLASTY BALLOON. THE PATIENT WAS CT SCANNED AND THE RADIOPAQUE MARKER WAS SEEN IN SOFT TISSUE IN THE COMMON FEMORAL ARTERY. THE ANGIOPLASTY BALLOON WAS NOT SEEN. BLOOD FLOW WAS NORMAL AT THIS TIME. AS FLOW WAS GOOD AND IT WAS ASSUMED THAT THE METAL MARKER REMAINED ATTACHED TO THE BALLOON, AND THAT THE BALLOON TOO, WAS IN THE SUBCUTANEOUS TISSUE. IT WAS DECIDED TO REMOVE THE BALLOON REMNANT ONCE THE GROIN HAD SETTLED DOWN AND HOMEOSTASIS WAS ASSURED, POSSIBLY THE NEXT MORNING. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT. THAT MORNING HIS LEG WAS FOUND TO BE COLD & BLUE AND IT WAS CLOTTED OFF FROM THE PUNCTURE SITE IN COMMON FEMORAL, DISTALLY. THERE NOW SEEMED TO BE SOME SORT OF OCCLUSION IN THE COMMON & SUPERFICIAL FEMORAL ARTERIES, BLOCKING THE PROFUNDA. THE POPLITEAL & PROFUNDA WERE FILLING VIA COLLATERALS. THE PATIENT WENT TO THE THEATRE FOR SURGERY TO FIND THE BALLOON. SURGERY WAS PERFORMED ON THE PATIENT AND THE BALLOON FRAGMENT WAS FOUND IN THE ARTERY PUNCTURE SITE, AND THE RADIOPAQUE MARKER WAS FOUND IN SUBCUTANEOUS TISSUE. FLOW WAS RE-ESTABLISHED IN THE COMMON FEMORAL ARTERY, SFA AND PROFUNDA. IT WAS REPORTED A WEEK LATER THAT THE PATIENT'S CONDITION DETERIORATED AND HAS SINCE REQUIRED AN ABOVE KNEE AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-PLAST XT PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. GFRL 1018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention