BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS BRIDGE BALLOON PREP KIT

    MDR report key: 7306780 · Received March 1, 2018

    Report

    Report Number
    1721504-2018-00022
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    October 31, 2017
    Report Date
    February 20, 2018
    Manufacturer
    MERIT MEDICAL SYSTEMS INC
    Product Code
    OJV
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE PATIENT PRESENTED WITH AN UNEXPLAINED CHRONIC FEVER. THE PATIENT HAD PREVIOUS DOCUMENTATION OF A PULMONARY EMBOLISM [PE] WITH MODERATE PULMONARY HYPERTENSION VIA A NUCLEAR SCAN. A TEE REVEALED VEGETATION. PHYSICIAN THINKS THAT THE PE IS LIKELY RELATED TO A SEPTIC EMBOLUS. ON (B)(6) 2017 -THE PHYSICIAN ALLEGES THAT DURING A TRANSVENOUS LEAD EXTRACTION A BALLOON WIRE WAS PLACED PROPHYLACTICALLY FOR POSSIBLE SVC PERFORATION DURING THE LEAD EXTRACTION PROCEDURE. THE PHYSICIAN REPORTED THAT THE BALLOON WAS INFLATED (NON-EMERGENTLY) AND DEFLATED WITHIN THE PATIENTS SVC, THEN PULLED BACK INTO THE IVC FOR THE REMAINDER OF THE PROCEDURE. THE PATIENT DEVELOPED THROMBUS. AN INTRAOPERATIVE TEE WAS ORDERED. THE PHYSICIAN NOTED AN ECHOGENIC MASS AS THE PROCEDURE PROGRESSED, THIS MASS RAPIDLY BECAME LARGER WITH ECHOGENICITY [SUSPICIOUS OF THROMBUS]. THE PATIENT WAS TESTED FOR HYPERCOAGULABLE STATUS WHICH WAS NEGATIVE. SHE WAS TREATED FOR 3 MONTHS WITH ANTICOAGULANTS. THE PHYSICIAN WAS CONCERNED THAT THE PROPHYLACTIC PLACEMENT COULD POTENTIALLY HAVE CAUSED THROMBOGENICITY. PATIENT-RELATED OUTCOMES POST-PROCEDURE ARE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151660 SPECTRANETICS BRIDGE BALLOON PREP KIT BALLOON PREP KIT OJV MERIT MEDICAL SYSTEMS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R BRIDGE OCCLUSION BALLOON (B)(6) 2017