BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK BALLOON DILATION CATHETER

    MDR report key: 2102901 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-01828
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED. THE 99-100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). DIRECT STENTING WAS PERFORMED WITH A 3.0X18MM PROMUS STENT AND POSTDILATION WAS PERFORMED WITH A 2.5X8MM MAVERICK BALLOON. UPON INITIAL BALLOON INFLATION, A DISSECTION WAS NOTED, WHICH WORSENED, RESULTING IN A PERFORATION. A NON BSC WIRE WAS ADVANCED TO THE LESION ALONG WITH A NON BSC STENT DELIVERY SYSTEM (SDS). THE NON BSC SDS WAS UNABLE TO CROSS THE LESION AND WHILE REMOVING THE DEVICE, THE NON BSC GUIDE WIRE BECAME ENTANGLED WITH THE FIRST NON BSC GUIDE WIRE THAT WAS PLACED IN THE LESION. WHILE TRYING TO REMOVE THE SECOND NON BSC WIRE, PART OF IT SHEARED OFF AND REMAINED IN THE MID TO DISTAL LAD. THE FIRST NON BSC WIRE WAS REMOVED WITHOUT DIFFICULTY. TWO NON BSC STENTS, SIZE 3.0X12MM, WERE IMPLANTED IN THE LESION AND SUCCESSFULLY SEALED THE PERFORATION AND ALSO EMBEDDED THE SEPARATED PORTION OF THE NON BSC GUIDE WIRE IN THE LESION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK BALLOON DILATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY UNK227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 3.0X18MM PROMUS STENT