BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI BRITE TIP UNKNOWN

    MDR report key: 3231327 · Received July 17, 2013

    Report

    Report Number
    9616099-2013-00454
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    October 1, 2003
    Report Date
    June 28, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: ZELLER ET AL TECHNOLOGICAL ADVANCES IN THE DESIGN OF CATHETERS AND DEVICES USED IN RENAL ARTERY INTERVENTIONS: IMPACT ON COMPLICATIONS; JOURNAL OF ENDOVASCULAR THERAPY, 2013:10:1006-1014. PLEASE NOTE THAT THE CATALOG AND LOT NUMBERS ARE NOT KNOWN. THE REPORTED EVENT WAS ASSOCIATED WITH THE VISTA BRITE TIP SHEATH. ZELLER ET AL TECHNOLOGICAL ADVANCES IN THE DESIGN OF CATHETERS AND DEVICES USED IN RENAL ARTERY INTERVENTIONS: IMPACT ON COMPLICATIONS; JOURNAL OF ENDOVASCULAR THERAPY, 2013:10:1006-1014; REPORT 10 ACCESS COMPLICATIONS WITH VISTA BRITE TIP AND IN MULTIPURPOSE CONFIGURATION. THERE WERE 4 FALSE ANEURYSMS (ALL SUCCESSFULLY TREATED BY DUPLEX-GUIDED COMPRESSION THERAPY. OF 6 LARGE GROIN HEMATOMAS, ONLY 1 REQUIRED BLOOD TRANSFUSION. FROM 1996 TO 2000, THE SAME OPERATOR PERFORMED ALL INTERVENTIONS; AS OF 2000, 2 MORE INTERVENTIONISTS JOINED THE TEAM. IN 301 (94%) OF THE 320 INTERVENTIONS, A GUIDING CATHETER (RDC [CORDIS ENDOVASCULAR, (B)(4)/GUIDANT, (B)(4)] OR VISTA BRITE TIP [CORDIS]) WAS USED VIA THE FEMORAL ACCESS (TABLE 2); IN 19 (6%) INTERVENTIONS, THE BRACHIAL APPROACH WAS USED WITH A 6-F, 90-CM MULTIPURPOSE GUIDING CATHETER OR 7-F GUIDING SHEATH (VISTA BRITE TIP IN MULTIPURPOSE CONFIGURATION). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. ACCESS SITE BLEEDS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. PATIENT AND/OR PHARMACOLOGICAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. ADEQUATE SHEATH REMOVAL TECHNIQUE AND PATIENT'S COMPLIANCE TO DECREASE MOBILITY OF LIMB AFFECTED IN ORDER TO PROMOTE COAGULATION ARE ROOT CAUSES OF PSEUDOANEURYSM AND HEMATOMA FORMATION. COMPLICATIONS SUCH AS HEMATOMAS CAN BE MORE PREVALENT IN OBESE PATIENTS. THERE MAY HAVE BEEN MULTIPLE PUNCTURES MADE TO THE FEMORAL ARTERY WHILE ATTEMPTING TO ACCESS IT WITH A SHEATH, WHICH MAY RESULT IN BLOOD SLOWLY OOZING INTO THE ADIPOSE TISSUE UNNOTICED UNTIL A HEMATOMA DEVELOPS. BASED ON THE INFORMATION PROVIDED AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    ZELLER ET AL TECHNOLOGICAL ADVANCES IN THE DESIGN OF CATHETERS AND DEVICES USED IN RENAL ARTERY INTERVENTIONS: IMPACT ON COMPLICATIONS; JOURNAL OF ENDOVASCULAR THERAPY, 2013:10:1006-1014; REPORT ACCESS COMPLICATIONS WITH VISTA BRITE TIP AND IN MULTIPURPOSE CONFIGURATION. THERE WAS 1 LARGE GROIN HEMATOMA WHICH REQUIRED BLOOD TRANSFUSION. FROM 1996 TO 2000, THE SAME OPERATOR PERFORMED ALL INTERVENTIONS; AS OF 2000, 2 MORE INTERVENTIONISTS JOINED THE TEAM. IN 301 (94%) OF THE 320 INTERVENTIONS, A GUIDING CATHETER (RDC [CORDIS ENDOVASCULAR, (B)(4)/GUIDANT, (B)(4)] OR VISTA BRITE TIP [CORDIS]) WAS USED VIA THE FEMORAL ACCESS (TABLE 2); IN 19 (6%) INTERVENTIONS, THE BRACHIAL APPROACH WAS USED WITH A 6-F, 90-CM MULTIPURPOSE GUIDING CATHETER OR 7-F GUIDING SHEATH (VISTA BRITE TIP IN MULTIPURPOSE CONFIGURATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330774 SI BRITE TIP UNKNOWN ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R