BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

    MDR report key: 2070198 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01550
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K960501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THE BALLOON WAS FOLDED HOWEVER, NOT WRAPPED AROUND THE SHAFT OF THE DEVICE. TRACES OF CLEAR LIQUID WERE PRESENT INSIDE THE BALLOON AND TRACES OF BLOOD NOTED INSIDE THE GUIDE WIRE LUMEN. THE BALLOON WAS UNABLE TO BE INFLATED TO ITS RATED BURST PRESSURE (RBP). THE DEVICE WAS SOAKED IN WARM WATER TO DISSOLVE ANY BUILD UP INSIDE THE SHAFT LUMEN. THE BALLOON WAS THEN INFLATED TO ITS NOMINAL PRESSURE OF 8 ATM AND NO LEAKS WERE NOTED. A VACUUM WAS PULLED AND THE BALLOON DEFLATED WITHIN ITS RECOMMENDED DEFLATION TIME. NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE 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 REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, DEFLATION DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN A NON CALCIFIED AND MODERATELY TORTUOUS SHUNT VEIN. THE PHYSICIAN ADVANCED THE 5.0MM X 10MM ULTRA-THIN DIAMOND BALLOON CATHETER TO THE LESION. THE BALLOON WAS INFLATED TO 15ATMS, THREE TIMES. UPON THE LAST DEFLATION, AIR ENTERED INTO THE DEVICE AND THE PHYSICIAN ENCOUNTERED DIFFICULTY DEFLATING THE BALLOON. 'THE PHYSICIAN MANAGED TO DEFLATE THE DEVICE, BUT IT WAS VERY HARD TO DO'. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, DEFLATION DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN A NON CALCIFIED AND MODERATELY TORTUOUS SHUNT VEIN. THE PHYSICIAN ADVANCED THE 5.0MM X 10MM ULTRA-THIN DIAMOND BALLOON CATHETER TO THE LESION. THE BALLOON WAS INFLATED TO 15ATMS, THREE TIMES. UPON THE LAST DEFLATION, AIR ENTERED INTO THE DEVICE AND THE PHYSICIAN ENCOUNTERED DIFFICULTY DEFLATING THE BALLOON. "THE PHYSICIAN MANAGED TO DEFLATE THE DEVICE, BUT IT WAS VERY HARD TO DO". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001164690 0013924584

    Patients

    Seq Age Sex Outcome Treatment
    1 5F ZEON INTRODUCER SHEATH| 0.035 RADIFOCUS GUIDE WIRE