BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? PLUS

    MDR report key: 3162729 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-03799
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION 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 ROTABLATION PROCEDURE, THE BURR BECAME STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY. A ROTALINK PLUS WAS SUCCESSFULLY USED TO BURR THROUGH THE LESION. DURING REMOVAL OF THE ROTALINK PLUS, THE BURR BECAME STUCK IN THE PROXIMAL LESION. ATTEMPTS WERE MADE TO SPIN THE BURR; HOWEVER, THE BURR STALLED. THE ROTALINK PLUS WOULD NOT MOVE FORWARD OR BACKWARDS. NITRO WAS ADMINISTERED ALONG WITH ADDITIONAL WIRING AND BALLOONING WITH ANOTHER MANUFACTURER¿S 1.25MM BALLOON CATHETER. THE PATIENT WAS SENT FOR BYPASS SURGERY AND THE BURR WAS SUCCESSFULLY REMOVED. NO PATIENT FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261813 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 15958276

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention