BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GUIDING CATHETER CARDIOLOGY

    MDR report key: 8566819 · Received April 30, 2019

    Report

    Report Number
    9616099-2019-02886
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    October 17, 2013
    Report Date
    April 30, 2019
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K971572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE DEVICE IS A SMART CONTROL STENT BUT THE LOT NUMBER IS NOT AVAILABLE. THE CITATION IS AS FOLLOWS: NELLES, M., GRESCHUS, S., MÖHLENBRUCH, M., SIMON, B., WÜLLNER, U., & URBACH, H. (2013). PATIENT SELECTION FOR MECHANICAL THROMBECTOMY. CLINICAL NEURORADIOLOGY, 24(3), 239-244. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE BY NELLES, M., GRESCHUS, S., MÖHLENBRUCH, M., SIMON, B., WÜLLNER, U., & URBACH, H. (2013). PATIENT SELECTION FOR MECHANICAL THROMBECTOMY. CLINICAL NEURORADIOLOGY, 24(3), 239-244. DOI:10.1007/S00062-013-0237-7; REPORTS THREE PATIENTS WITH INTRACEREBRAL POSTPROCEDURAL HEMORRHAGE (ICH) AFTER RECANALIZATION THERAPY UTILIZING AN 8 FRENCH VISTA BRITE TIP GUIDING CATHETER. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. THE MOST COMMON CAUSE OF INTRACEREBRAL HEMORRHAGE IS HIGH BLOOD PRESSURE (HYPERTENSION). AFTER REVASCULARIZATION THAT ALLEVIATES A HIGH-GRADE SYMPTOMATIC STENOTIC LESION, CEREBRAL HYPERPERFUSION MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS. ANTICOAGULATION IS A KNOWN RISK FACTOR FOR BRAIN HEMORRHAGE IN PATIENTS WITH PRE-EXISTING DISEASE. LESS COMMON CAUSES OF INTRACEREBRAL HEMORRHAGE INCLUDE TRAUMA, INFECTIONS, TUMORS, BLOOD CLOTTING DEFICIENCIES, AND ABNORMALITIES IN BLOOD VESSELS (SUCH AS ARTERIOVENOUS MALFORMATIONS). TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POST PROCEDURE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. GIVEN THE LIMITED INFORMATION PROVIDED, AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS OR PROCEDURAL FILMS, THE REPORTED EVENT COULD NOT BE CONFIRMED, AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. PATIENT AND/OR PHARMACOLOGICAL FACTORS ARE ALSO LIKELY CONTRIBUTING FACTORS. WITHOUT A LOT NUMBER TO CONDUCT A DEVICE HISTORY RECORD (DHR) REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE BY NELLES, M., GRESCHUS, S., MÖHLENBRUCH, M., SIMON, B., WÜLLNER, U., & URBACH, H. (2013). PATIENT SELECTION FOR MECHANICAL THROMBECTOMY. CLINICAL NEURORADIOLOGY, 24(3), 239-244. DOI:10.1007/S00062-013-0237-7; REPORTS THREE PATIENTS WITH INTRACEREBRAL POSTPROCEDURAL HEMORRHAGE (ICH) AFTER RECANALIZATION THERAPY UTILIZING AN 8 FRENCH VISTA BRITE TIP GUIDING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359414 UNKNOWN GUIDING CATHETER CARDIOLOGY CATHETER, PERCUTANEOUS DQY CORDIS CORPORATION XXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening