BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTOME CUTTING BALLOON

    MDR report key: 2103535 · Received May 26, 2011

    Report

    Report Number
    2134265-2011-01957
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR. #: 2939204-2011-00302, 2939204-2011-00318, 2134265-2011-01976. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A VESSEL DISSECTION OCCURRED. IVUS WAS PERFORMED TO DETERMINE RESTENOSIS VS. IN-STENT RESTENOSIS. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS CIRCUMFLEX (CX) ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE ATLANTIS PRO SR IMAGING CATHETER TO THE LESION HOWEVER, THE CATHETER KEPT BUCKLING AND KINKED BETWEEN THE DISTAL MARKER AND THE TRANSDUCER. THE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND ATLANTIS PRO SR IMAGING CATHETER WAS ADVANCED TO THE LESION AND IN-STENT RESTENOSIS OF A NON-BSC STENT WAS CONFIRMED. THE PHYSICIAN THEN ADVANCED A 2.5MM X 6MM FLEXTOME CUTTING BALLOON AND THE BALLOON WAS INFLATED ONCE TO AN UNSPECIFIED PRESSURE. THE CUTTING BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT WITHOUT ISSUE. A "HEMATOMA DISSECTION" WAS NOTED. IT COULD NOT BE DETERMINED IF EITHER OF THE IMAGING CATHETERS, THE CUTTING BALLOON OR THE MACH1 6F GUIDE CATHETER CAUSED THE DISSECTION AS THE GUIDE CATHETER WAS DEEP SEATED. THE DISSECTION WAS TREATED WITH A 4.0MM X 8.0MM TAXUS LIBERTE STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749CBM3250060 13576084

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ATLANTIS SR PRO IMAGING CATHETER X 2| MACH1 6F GUIDE CATHETER