BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 1983766 · Received February 10, 2011

    Report

    Report Number
    2134265-2011-00353
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    November 17, 2010
    Report Date
    January 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED INSIDE A 7 FRENCH INTRODUCER SHEATH. THE INITIAL EXAMINATION OF THE RETURNED DEVICE REVEALED NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE, HOWEVER IT WAS NOTED WHEN THE SHEATH WAS PULLED BACK THAT THE SHAFT PROXIMAL TO THE BALLOON BOND WAS DAMAGED (SMALL DENTS/MARKS) NOTED IN THE SHAFT). THE TIP OF THE DEVICE AND 80MM OF THE DISTAL SECTION OF THE BALLOON WAS SLIGHTLY FLARED AND WAS NOT WRAPPED AROUND THE SHAFT OF THE DEVICE. THE SHEATH WAS PULLED BACK AND IT WAS NOTED THAT 45MM OF THE PROXIMAL SECTION OF THE BALLOON WAS FOLDED AND WRAPPED AROUND THE SHAFT. THERE WERE TRACES OF BLOOD ON THE BALLOON. THE DISTAL END OF THE SHEATH WAS DAMAGED AND JAGGED LOOKING. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS INFLATED WHEN A LEAK WAS NOTED. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL OBSERVED A 2MM CIRCUMFERENTIAL TEAR HAD OCCURRED IN THE BALLOON MATERIAL 3MM PROXIMAL TO THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. THE BALLOON MATERIAL WAS SEVERELY CREASED. 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 CLASSIFICATION OF THIS INVESTIGATION IS USER/USE ERROR BECAUSE THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE DIRECTIONS FOR USE (DFU) AND /OR ANY USE NOT CONSIDERED ACCEPTED GENERAL MEDICAL PRACTICE. THIS ROOT CAUSE IS ASSIGNED DUE TO THE PHYSICIAN USING THE DEVICE IN THE AORTA JUST BELOW THE RENAL ARTERIES. HOWEVER, THE DFU STATES THE XXL BALLOON DILATATION CATHETER IS INTENDED FOR USE IN ADULT AND ADOLESCENT POPULATIONS TO DILATE STRICTURES OF THE ESOPHAGUS AND THIS IS THEREFORE OFF LABEL USE. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-05769. ORIGINALLY THIS WAS TO BE REPORTED ON THE 4TH QUARTER ALTERNATIVE SUMMARY REPORT. BASED UPON ANALYSIS ON (B)(6) 2011, THIS WILL NOW BE REPORTED AS AN INDIVIDUAL MDR. IT WAS REPORTED THAT DURING AN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT A BALLOON RUPTURE OCCURRED. THE PATIENT HAD STENOSIS OF THE AORTA JUST BELOW THE RENAL ARTERIES. THE PHYSICIAN ATTEMPTED TO INSERT THE 6F SHEATH AND ADVANCE THE GUIDE WIRE TO THE INTENDED LOCATION AND THEN ATTEMPTED TO INSERT THE XXL/18-6/5.8/75 BALLOON THROUGH THE SHEATH. THE BALLOON WAS STUCK AND WOULD NOT GO THROUGH. THE PHYSICIAN THEN REMOVED THE BALLOON AND THE SHEATH AS A UNIT. HE THEN PULLED A 7F NON BOSTON SCIENTIFIC SHEATH AND ADVANCED THE SAME BALLOON THROUGH THE SHEATH WITH NO ISSUES. THE BALLOON WAS INFLATED BUT WAS NOT SATISFIED WITH IT. WHEN THE PHYSICIAN INFLATED THE XXL BALLOON THE TAPERED ENDS OF THE BALLOON INFLATED AS WELL, THEREFORE THE XXL BALLOON WAS NOT POSITIONED CORRECTLY. HE REMOVED THE BALLOON WITH OUT ANY DIFFICULTY FROM THE SHEATH AND RE-INFLATED OUTSIDE THE PATIENT. AS THE BALLOON HAD BEEN INFLATED TWICE, IT WOULD NOT GO BACK INSIDE THE 7F SHEATH AS THE REWRAP WAS NOT GOOD. THE BALLOON WAS DISCARDED. HE PULLED A XXL/18-6/5.8/75 BALLOON AND PLACED IT WITHOUT DIFFICULTY OVER THE LESION AND INFLATED ONCE FOR A FULL MINUTE AT FIVE ATMOSPHERES. THE BALLOON WAS REMOVED AND IT APPEARED TO HAVE BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XXL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001145590 0013727546

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR XXL/18-6/5.8/75| 6FR SUPER SHEATH