BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE MAX BALLOON DILATATION CATHETER

    MDR report key: 1130944 · Received August 21, 2008

    Report

    Report Number
    2134265-2008-02404
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE, WITHDRAWAL DIFFICULTIES AND A SHAFT FRACTURE OCCURRED. THE 6CM LONG LESION WAS A HIGH-GRADE STENOSIS LOCATED IN A LEFT AXILLARY VEIN STENT. THE PATIENT PRESENTED WITH SEVERE PAIN DURING HEMODIALYSIS. THE AV DIALYSIS ACCESS WAS CANNULATED IN ANTEGRADE FASHION WITH SINGLE-WALL NEEDLE. THE BLUE MAX BALLOON CATHETER WAS ADVANCED TO THE LESION AND DILATED TO 18ATMS FOR TWO INFLATIONS, 45 SECONDS AND 44 SECONDS. THE BLUE MAX BALLOON RUPTURED ON THE SECOND INFLATION. DURING WITHDRAWAL THROUGH THE 7FR SHEATH, THE CATHETER SEPARATED. THE BALLOON WAS PARTIALLY SNARED OUT HOWEVER THE BALLOON CATHETER TIP REMAINED IN THE PATIENT. THE PATIENT WENT SURGERY TO REMOVE THE REMAINING PORTION. DURING SURGERY THE FOLLOWING DAY A DIRECT CUT-DOWN WAS MADE AND THE DEVICE WAS REMOVED. PATIENT STATUS FOLLOWING SURGERY WAS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE MAX BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLATY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention 7FR SUPER SHEATH