BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON

    MDR report key: 2222954 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03676
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    May 30, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE RETURNED BALLOON SHOWED EVIDENCE OF BEING INFLATED WITH BLOOD IN THE BALLOON AND CONGEALED CONTRAST MEDIA IN THE SHAFT. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND AN ATTEMPT WAS MADE TO INFLATE THE DEVICE TO ITS RATED BURST PRESSURE (RBP) BUT THE DEVICE COULD NOT BE INFLATED DUE TO THE CONGEALED CONTRAST MEDIA. THE BALLOON WAS IMMERSED IN WATER AND A PINHOLE LEAK WAS OBSERVED FROM THE AIR BUBBLES COMING FROM THE BALLOON. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL OBSERVED THAT THE PINHOLE LEAK WAS AT THE PROXIMAL END OF THE BLADES. THE BALLOON RUPTURED AT 12ATMS ON THE THIRD INFLATION. NO OTHER DAMAGE TO THE DEVICE WAS NOTED. THE MANUFACTURING BATCH REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIALS, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED (B)(4)-2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE TREATMENT A CUTTING BALLOON RUPTURE OCCURRED. ACCESSED WAS OBTAINED VIA A CONTRA LATERAL APPROACH THROUGH THE FEMORAL ARTERY. THE TARGET LESION WAS 90% STENOSED AND LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN TREATED THE LESION USING A SPCB FLEXTOME MONORAIL 4.00MM/1.5CM/140CM BALLOON CATHETER. IT WAS DILATED AT 12ATMS AND ON THE THIRD INFLATION THE BALLOON RUPTURED. TRAUMA TO THE ARTERIOVENOUS FISTULA OCCURRED WHICH WAS TREATED WITH A LONG INFLATION TO THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL PERIPHERAL CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 14274162

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention