BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING¿

    MDR report key: 2894969 · Received January 3, 2013

    Report

    Report Number
    2134265-2012-08148
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: UPDATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED BRADYCARDIA AND CARDIAC ARREST. THE LESION BEING TREATED WAS LOCATED IN THE CAROTID ARTERY. THE PHYSICIAN USED GENERAL ANESTHESIA. THE PHYSICIAN PREDILATED WITH A NON-BSC BALLOON CATHETER AND DEPLOYED A FILTER WIRE. THE PHYSICIAN INFLATED A 5.5 X 40MM X 135CM STERLING BALLOON CATHETER IN THE TARGET LESION BEFORE IMPLANTING AN UNKNOWN CAROTID WALL STENT. USING THE SAME BALLOON CATHETER THE PHYSICIAN INFLATED THE BALLOON TO NOMINAL PRESSURE AND BRADYCARDIA AND CARDIAC ARREST OCCURRED. THE PHYSICIAN PERFORMED CARDIAC MASSAGE AND VASOPRESSOR. THE PATIENT RECOVERED TO A HEART RATE OF 83 AFTER APPROXIMATELY 10 SECONDS. THE PHYSICIAN FELT IT MAY HAVE BEEN DUE TO VAGUS NERVE STIMULATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AFTER THE PATIENT RECOVERED TO A HEART RATE OF 83, A STOP FLOW WAS NOTED ON THE ANGIOGRAPHY AND THE THROMBOSIS WAS CAPTURED BY THE IMPLANTED FILTERWIRE EZ. A NON-BSC DEVICE WAS USED TO PERFORM THROMBECTOMY FROM THE FILTERWIRE EZ AND THEN IT WAS REMOVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2771 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031554010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention