BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TEMPO 4F

    MDR report key: 8582596 · Received May 6, 2019

    Report

    Report Number
    9616099-2019-02902
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    November 18, 2006
    Report Date
    May 6, 2019
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K973401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DABITZ, R., TRIEBE, S., LEPPMEIER, U., OCHS, G., & VORWERK, D. (2007). "PERCUTANEOUS RECANALIZATION OF ACUTE INTERNAL CAROTID ARTERY OCCLUSIONS IN PATIENTS WITH SEVERE STROKE." CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 34-41. DOI: 10.1007/S00270-005-0286-7. AS REPORTED IN THE LITERATURE BY DABITZ, R., TRIEBE, S., LEPPMEIER, U., OCHS, G., & VORWERK, D. (2006). "PERCUTANEOUS RECANALIZATION OF ACUTE INTERNAL CAROTID ARTERY OCCLUSIONS IN PATIENTS WITH SEVERE STROKE." CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 30 (1), 34-41. DOI: 10.1007/S00270-005-0286-7; TWO PATIENTS HAD A SINGLE EPISODE OF CONVULSIVE OR EPILEPTIC SEIZURES POSTOPERATIVELY. THE PROCEDURE WAS A RECANALIZATION OF THE INTERNAL CAROTID ARTERY (ICA) IN PATIENTS WHO PRESENTED WITH SEVERE ACUTE CEREBRAL ISCHEMIA ASSOCIATED WITH AN OCCLUSION OF THE PROXIMAL CAROTID ARTERY. A STANDARD 4FR CORDIS HEADHUNTER CATHETER AND AN 8FR VISTA BRITE CAROTID GUIDING SHEATH WERE USED IN THE PROCEDURE. THE DEVICES WERE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBERS WERE NOT PROVIDED. CONVULSIONS (OR SEIZURES) ARE SUDDEN, VIOLENT, IRREGULAR MOVEMENTS OF A LIMB OR OF THE BODY CAUSED BY INVOLUNTARY MUSCLE CONTRACTIONS DUE TO A DISORDER OF THE NERVOUS SYSTEM¿S ELECTRICAL ACTIVITY. THIS IS A NEUROLOGICAL SYMPTOM THAT CAN OCCUR AFTER A CAROTID ANGIOPLASTY/STENTING PROCEDURES. THIS SYMPTOM CAN BE DUE TO THROMBUS OR DEBRIS TRAVELING TO THE BRAIN AND RESTRICTING BLOOD FLOW; OR EVEN DUE TO THE SUDDEN INCREASE IN CEREBRAL BLOOD FLOW SEEN IN CEREBRAL HYPERPERFUSION SYNDROME (CHS) AFTER A SUCCESSFUL PROCEDURE. HOWEVER, THE CAUSE OF THE REPORTED CONVULSION WAS NOT PROVIDED, AND IT IS NOT POSSIBLE TO DETERMINE WHETHER THE CORDIS CATHETERS OR CORDIS GUIDING SHEATHS HAD CONTRIBUTED TO THE EVENTS, ESPECIALLY SINCE THEY OCCURRED POST-OPERATIVELY. PROCEDURAL FACTORS AND PATIENT FACTORS MOST LIKELY CONTRIBUTED TO EVENT. THE REPORTED EVENT COULD NOT BE CONFIRMED. WITHOUT A LOT NUMBER TO CONDUCT A PHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE REPORTING REFERENCE NUMBER FOR THE RELATED EVENT IS 9616099-2019-02901.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE BY DABITZ, R., TRIEBE, S., LEPPMEIER, U., OCHS, G., & VORWERK, D. (2006). "PERCUTANEOUS RECANALIZATION OF ACUTE INTERNAL CAROTID ARTERY OCCLUSIONS IN PATIENTS WITH SEVERE STROKE." CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 30 (1), 34-41. DOI: 10.1007/S00270-005-0286-7; TWO PATIENTS HAD A SINGLE EPISODE OF CONVULSIVE OR EPILEPTIC SEIZURES POSTOPERATIVELY. THE PROCEDURE WAS A RECANALIZATION OF THE INTERNAL CAROTID ARTERY (ICA) IN PATIENTS WHO PRESENTED WITH SEVERE ACUTE CEREBRAL ISCHEMIA ASSOCIATED WITH AN OCCLUSION OF THE PROXIMAL CAROTID ARTERY. A STANDARD 4FR CORDIS HEADHUNTER CATHETER AND AN 8FR VISTA BRITE CAROTID GUIDING SHEATH WERE USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375347 UNKNOWN TEMPO 4F CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S UNK BRITE TIP