BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE CATHETER

    MDR report key: 20706874 · Received November 18, 2024

    Report

    Report Number
    3008114965-2024-01134
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    August 16, 2007
    Report Date
    November 18, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DQY
    PMA / PMN Number
    K000715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. SECTION H4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. CLINICIAN ASSESSMENT: ALTHOUGH NO SPECIFIC INTERVENTION IS STATED, A THROMBOEMBOLISM IS CONSIDERED A SERIOUS INJURY THAT IS LIFE THREATENING AND MAY RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR CAN REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THEREFORE, THE EVENT IS REPORTABLE TO THE US FDA. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ZENTENO MA, SANTOS-FRANCO JA, FREITAS-MODENESI JM, GÓMEZ C, MURILLO-BONILLA L, ABURTO-MURRIETA Y, DÍAZ-ROMERO R, NATHAL E, GÓMEZ-LLATA S, LEE A. USE OF THE SOLE STENTING TECHNIQUE FOR THE MANAGEMENT OF ANEURYSMS IN THE POSTERIOR CIRCULATION IN A PROSPECTIVE SERIES OF 20 PATIENTS. J NEUROSURG. 2008 JUN;108(6):1104-18. DOI: 10.3171/JNS/2008/108/6/1104. PMID: 18518712. OBJECT. THE USE OF INTRACRANIAL STENTS IN STENT-ASSISTED COIL EMBOLIZATION IS NOW A CURRENT NEUROSURGICAL PRACTICE WORLDWIDE. THE CLINICAL UTILITY OF THESE STENTS IN THE SOLE STENTING (SS) TECHNIQUE, HOWEVER, HAS NOT BEEN THOROUGHLY DESCRIBED AND THE PUBLISHED REPORTS OF THIS EXPERIENCE ARE SCARCE. THIS STUDY WAS DESIGNED TO EVALUATE SS TREATMENT OF DISSECTING AND NONDISSECTING ANEURYSMS OF THE POSTERIOR CIRCULATION. METHODS. THIS PROSPECTIVE AND DESCRIPTIVE STUDY WAS CONDUCTED IN 20 CONSECUTIVE PATIENTS WHO HARBORED SINGLE ANEURYSMS OF THE POSTERIOR CIRCULATION AND WHO WERE TREATED USING THE SS APPROACH IN THE LAST 3 YEARS. THE CLINICAL AND RADIOLOGICAL ASSESSMENT AND FOLLOW-UP OF THE PATIENTS WERE EVALUATED USING THE MODIFIED RANKIN SCALE AS WELL AS WITH COMPUTED TOMOGRAPHY ANGIOGRAPHY AND DIGITAL SUBTRACTION ANGIOGRAPHY AT DISCHARGE AND AT 1, 3, 6, AND 12 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK: 6 FR ENVOY GUIDING CATHETER . NON-CERENOVUS DEVICES THAT WERE USED IN THIS STUDY: 7 FR INTRODUCER SHEATH (UNKNOWN MANUFACTURER), AND EXPRESS STENT (BOSTON SCIENTIFIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH THE UNK: 6 FR ENVOY GUIDING CATHETER (QTY 1). - PATIENT 3, A 40-YEAR-OLD FEMALE HAD AN ISCHEMIC STROKE OCCURRED DUE TO AN EMBOLUS FROM THE GUIDING CATHETER. BECAUSE THE LESION WAS IN THE RIGHT OCCIPITAL AREA, THE PATIENT DEVELOPED A LEFT HOMONYMOUS QUADRANTANOPSIA THAT PROGRESSIVELY DISAPPEARED 6 MONTHS LATER. THE ANTIPLATELET TREATMENT DID NOT AFFECT CEREBROSPINAL FLUID SHUNTING PROCEDURES. -THE REST OF THE ADVERSE EVENTS AND/OR MALFUNCTIONS MENTIONED IN ARTICLE ARE ASSOCIATED WITH COMPETITOR PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591576 GUIDE CATHETER PERCUTANEOUS CATHETER DQY MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Life Threatening 7 FR INTRODUCER SHEATH (UNKNOWN MANUFACTURER).| EXPRESS STENT (BOSTON SCIENTIFIC).