BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI BRITE TIP UNKNOWN

    MDR report key: 3070769 · Received April 22, 2013

    Report

    Report Number
    9616099-2013-00236
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS NOT ASSOCIATED WITH THE PREVIOUSLY REPORTED PERFORATION. THEREFORE, NO FURTHER REPORTS WILL BE FORTHCOMING INVOLVING THIS DEVICE OR THE ASSOCIATED MANUFACTURING REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE CATALOG NUMBER INDICATED REPRESENTS AND UNKNOWN BRITE TIP SHEATH. THE CATALOG AND LOT NUMBERS ARE NOT CURRENTLY AVAILABLE. THIS DEVICE IS ALSO NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2013-00163 AND 9616099-2013-00236.

    Description of Event or Problem · 1

    AS PER A VOLUNTARY MEDWATCH REPORT FILED WITH THE FDA. "ANGIOGRAM IN PROCESS CATHETER FRACTURED WHILE TRYING TO ACCESS THE LEFT COMMON CAROTID ARTERY. PT HAD TO BE TAKEN TO THE OPERATING ROOM FOR EMERGENCY RIGHT FEMORAL CUTDOWN AND EXPLORATION OF RIGHT RETROPERITONEUM FOR REMOVAL OF CATHETER AND REPAIR OF PERFORATED MID RIGHT EXTERNAL ILIAC ARTERY." A BRITE TIP SHEATH WAS USED IN THE PROCEDURE AND IT IS UNCLEAR AT THIS TIME WHICH OF THE TWO DEVICES CAUSED THE PERFORATION. THE INITIAL REPORT INDICATED THAT A 5F SUPERTORQUE DIAGNOSTIC CATHETER FRACTURED IN THE PATIENT REQUIRING SURGICAL REMOVAL. THE DEVICE SEPARATED ABOUT 10 INCHES FROM THE HUB AND WAS USED TO SELECT A CAROTID ARTERY AND FRACTURED WHEN THE PHYSICIAN MANIPULATED IT FROM THE RIGHT TO LEFT CAROTID ARTERY. THE PROCEDURE BEING PERFORMED WAS A DIAGNOSTIC CEREBRAL ANGIOGRAM AND THE DIAGNOSTIC CATHETER WAS INSIDE OF THE PATIENT FOR A FEW MINUTES TO TAKE PICTURES OF THE CAROTID AND VERTEBRAL ARTERIES. THE VESSEL CHARACTERISTICS OF THE VESSEL USED TO DELIVER THE CATHETER TO THE TARGET SITE WAS A TYPE II ARCH AND MILD CALCIFICATION. A CORDIS BRITE TIP SHEATH WAS USED IN THE PROCEDURE. ACCESS WAS VIA THE COMMON FEMORAL ARTERY. THE TARGET LESION WAS MODERATELY CALCIFIED, ANGULATED AND WITH MILD VESSEL TORTUOSITY. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. PICTURES WERE ALSO REQUESTED BUT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171167 SI BRITE TIP UNKNOWN ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 5F SUPERTORQUE