BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2CM PERIPHERAL CUTTING BALLOON®

    MDR report key: 2181792 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03398
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE 8.00MM X 2.0CM X 90CM PCB OTW CUTTING BALLOON FOUND THAT THE RETURNED DEVICE SHOWED EVIDENCE OF BEING INFLATED WITH BLOOD IN THE SHAFT. THE Y-SITE WAS DETACHED FROM THE DEVICE AND NOT RETURNED. THE BALLOON WAS RETURNED DEFLATED, HOWEVER THE DEVICE COULD NOT BE TESTED FOR INFLATION AND DEFLATION AS THE Y-SITE WAS DETACHED. THE DEVICE WAS SUCCESSFULLY ADVANCED AND WITHDRAWN THROUGH A 7FR TEST SHEATH WITHOUT ISSUE. NO OTHER DAMAGE TO THE DEVICE WAS NOTED. THE MANUFACTURING RECORD CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLY ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT VASCULAR ACCESS WAS GAINED VIA A LEFT MID UPPER ARM BRACHIAL VEIN. TARGET LESIONS WERE LOCATED IN THE RIGHT ATRIAL JUNCTION AND LEFT INNOMINATE VEIN JUNCTION OF THE SUPERIOR VENA CAVA. THE 8.00MM X 2.0CM X 90CM PCB OTW CUTTING BALLOON WAS INFLATED TO 10ATMS. TO REMOVE THE DEVICE FROM THE 7-FRENCH X 30CM SHEATH, VASCULAR ACCESS WAS GAINED VIA THE RIGHT COMMON FEMORAL VEIN. A 15MM LOOP SNARE WAS USED TO ENGAGE A 0.018 UNKNOWN GUIDEWIRE IN THE RIGHT EXTERNAL ILIAC VEIN AND EXTRACT IT FROM THE FEMORAL SHEATH. THE SNARE WAS AGAIN ADVANCED OVER THE WIRE AND USED TO MANUALLY COMPRESS THE CUTTING BALLOON TO REDUCE ITS PROFILE. THE DISTAL END OF THE BALLOON WAS THEN ENGAGED AND THE SNARE WAS FORCEFULLY CONTRACTED ALLOWING THE CUTTING BALLOON TO BE WITHDRAWN INTO THE 9-FRENCH FEMORAL SHEATH. NEXT, THE SHAFT OF THE BALLOON CATHETER WAS CUT AT THE LEFT BRACHIAL ACCESS SITE INTO THE SHEATH AND WAS THEN SUCCESSFULLY REMOVED FROM THE GROIN. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UNSPECIFIED TREATMENT PROCEDURE DEFLATION DIFFICULTIES AND WITHDRAWAL DIFFICULTIES OCCURRED. THE 8.00MM X 2.0CM X 90CM PCB OTW CUTTING BALLOON WAS USED TO TREAT A LESION IN AN UNSPECIFIED VESSEL. UPON REMOVAL, THE DEVICE WAS UNABLE TO BE PULLED BACK INTO THE UNKNOWN MANUFACTURER'S SHEATH. THE INTRODUCER SHEATH WAS EXCHANGED FOR A LARGER SHEATH TO ALLOW FOR THE CUTTING BALLOON TO BE REMOVED. IT WAS NOTED THAT THE CUTTING BALLOON MAY NOT HAVE DEFLATED COMPLETELY WHICH MAY HAVE BEEN THE REASON THE DEVICE WAS UNABLE TO BE RESHEATHED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB8020900 14263277

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INDRODUCER SHEATH: 7-FRENCH X 30 CM