BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA 2 CUTTING BALLOON

    MDR report key: 1783667 · Received August 4, 2010

    Report

    Report Number
    2134265-2010-03577
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED: PMA# OR 510(K)# CORRECTED FROM K040155 TO P950020. BRAND NAME CORRECTED FROM CUTTING BALLOON TO ULTRA 2 CUTTING BALLOON. COMMON DEVICE NAME CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS. DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE BALLOON HAD EVIDENCE OF BEING INFLATED WITH CONGEALED CONTRAST MEDIA IN THE BALLOON AND SHAFT. THERE WAS NO DAMAGE NOTED TO THE SHAFT. A 0.014" WIRE WAS INSERTED THROUGH THE WIRE LUMEN AND REMOVED WITHOUT ISSUE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT BUT IT COULD NOT BE INFLATED DUE TO THE CONTRAST MEDIA. THE DEVICE WAS SOAKED IN WARM WATER AND A LEAK WAS NOTED IN THE BALLOON. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON OBSERVED A PINHOLE LEAK IN THE CENTER OF THE BALLOON. A BLADE MARK WAS NOTED AT THE LEAK AREA. THERE WAS SLIGHT DAMAGE NOTED TO THE DISTAL TIP OF THE DEVICE. NO OTHER DAMAGE WAS NOTED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, ANOTHER MANUFACTURER'S GUIDE WIRE BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% IN-STENT RESTENOSIS WAS LOCATED IN THE MILDLY TORTUOUS FIRST DIAGONAL (DX) ARTERY AND PROTECTED LEFT MAIN. THE UNSPECIFIED CUTTING BALLOON WAS BEING USED WITH ANOTHER MANUFACTURER'S GUIDE WIRE TO POST-DILATE A STENT AND UPON REMOVAL OF THE CUTTING BALLOON, THE TIP OF THE GUIDE WIRE BROKE OFF IN THE DIAGONAL ARTERY. ATTEMPTS TO SNARE THE FRACTURED GUIDE WIRE TIP WERE MADE WITH A GOOSENECK MICROSNARE BUT WERE UNSUCCESSFUL AND THE FRACTURED GUIDE WIRE TIP WAS LEFT IN THE DIAGONAL ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED IN THE PROTECTED LEFT MAIN. FOUR UNSPECIFIED BALLOON CATHETER WERE USED FOR PRE AND POST DILATATIONS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, ANOTHER MANUFACTURER'S GUIDE WIRE BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% IN-STENT RESTENOSIS WAS LOCATED IN THE MILDLY TORTUOUS FIRST DIAGONAL (DX) ARTERY AND PROTECTED LEFT MAIN. THE UNSPECIFIED CUTTING BALLOON WAS BEING USED WITH ANOTHER MANUFACTURER'S GUIDE WIRE TO POST-DILATE A STENT AND UPON REMOVAL OF THE CUTTING BALLOON, THE TIP OF THE GUIDE WIRE BROKE OFF IN THE DIAGONAL ARTERY. ATTEMPTS TO SNARE THE FRACTURED GUIDE WIRE TIP WERE MADE WITH A GOOSENECK MICROSNARE, BUT WERE UNSUCCESSFUL AND THE FRACTURED GUIDE WIRE TIP WAS LEFT IN THE DIAGONAL ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED IN THE PROTECTED LEFT MAIN. FOUR UNSPECIFIED BALLOON CATHETERS WERE USED FOR PRE AND POST DILATATIONS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA 2 CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749CBM250150

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4 BALLOON CATHETERS| 6F XB 3.5 CORDIS GUIDE CATHETER| STENT| EV-3 AMPLATZ GOOSENECK MICROSNARE| PROWATERFLEX WIRE