BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROWLER MICROCATHETERS

    MDR report key: 1623898 · Received March 8, 2010

    Report

    Report Number
    1058196-2010-00062
    Event Type
    Injury
    Date Received
    March 8, 2010
    Date of Event
    May 5, 2009
    Report Date
    February 9, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K972518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT #1058196-2010-00061 & 1058196-2010-00062. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A PROWLER 14 MICROCATHETER AND AGILITY 14 GUIDEWIRE WERE USED DURING THE INDEX PROCEDURE IN WHICH THE PATIENT WAS TREATED EMERGENTLY TO DISSOLVE THROMBUS IN AN UNKNOWN LOCATION. IT WAS REPORTED THAT THERE WERE NO ISSUES DURING THE PROCEDURE. AFTER ABOUT 1 WEEK, THE PATIENT APPEARED WITH SYMPTOMS OF PARALYSIS AND WAS HOSPITALIZED AND PRODUCT INFORMATION WAS REQUESTED FOR FURTHER EVALUATION. IN RESPONSE TO INVESTIGATIONAL EFFORTS, IT WAS REPORTED THAT THERE IS NO FURTHER INFORMATION REGARDING THE TREATMENT SITE, PATIENT¿S STATUS PRIOR TO THE PROCEDURE, AFTER THE PROCEDURE, OR AT THE TIME OF RE-HOSPITALIZATION. IT WAS REPORTED THAT THERE WERE NO INTRA-PROCEDURAL OR POST PROCEDURAL ADVERSE EVENTS. AFTER THE PROCEDURE, THE PATIENT WAS PLACED ON UNKNOWN ANTIPLATELET OR ANTICOAGULATION THERAPY, AND THE PATIENT WAS COMPLIANT WITH MEDICATION AND MEDICAL REGIMEN. NO OTHER DEVICES WERE UTILIZED TO TREAT THE PATIENT DURING THE INDEX PROCEDURE. THERE IS NO INFORMATION REGARDING THE PATIENT¿S MEDICAL HISTORY PRIOR TO THE PROCEDURE. THERE IS NO FURTHER INFORMATION REGARDING THE REPORTED PARALYSIS ONE WEEK LATER OR RELATED MEDICAL FINDINGS. IT HAS BEEN REPORTED THAT THE MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. THE PROWLER 14 IS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. DUE TO THE LACK OF INFORMATION REGARDING THE INDEX PROCEDURE AND THE EVENT, NO CONCLUSION CAN BE MADE REGARDING A RELATIONSHIP OF REPORTED PARALYSIS ONE WEEK POST PROCEDURE AND THE PROWLER 14 AND AGILITY 14 USED TO DISSOLVE AN EXISTING THROMBUS. IT IS POSSIBLE THAT PATIENT MEDICAL CONDITION, ADMINISTRATION OF THROMBOLYTICS AND VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, NO CONCLUSION CAN BE MADE. BASED ON THE LACK OF INFORMATION, THE REPORT THAT THERE WERE NO ISSUES DURING THE PROCEDURE OR POST PROCEDURE, AND THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE PARALYSIS IS RELATED TO ANY CORDIS DEVICE, DEVICE DESIGN, MANUFACTURING PROCESS, OR DEVICE MALFUNCTION. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT #1058196-2010-00061 & 1058196-2010-00062.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT WAS TREATED EMERGENTLY TO DISSOLVE THROMBUS WITH A PROWLER 14 AND AGILITY 14 GUIDEWIRE. NO ISSUE HAPPENED DURING THE PROCEDURE. AFTER ABOUT 1 WEEK, THE PATIENT APPEARED WITH PARALYSIS SYMPTOM AND WAS HOSPITALIZED. CURRENTLY, THE PATIENT¿S FAMILY ASKED FOR THE PRODUCT DOCUMENT FOR FURTHER EVALUATION. ADDITIONALLY IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT WAS PLACED ON UNKNOWN ANTIPLATELET OR ANTICOAGULATION THERAPY, AND THE PATIENT WAS COMPLIANT WITH MEDICATION AND MEDICAL REGIMEN. NO OTHER DEVICES WERE UTILIZED TO TREAT THE PATIENT DURING THE INDEX PROCEDURE ONLY THE AGILITY 14 GUIDEWIRE ((B) (4)) AND PROWLER MC 14 ((B) (4)). AFTER THE PROCEDURE, NO ADVERSE EVENTS OCCURRED. THE CURRENT PATIENT CONTINUES TO EXPERIENCED PARALYSIS. THE FILES OF THE PATIENT ARE KEPT IN HOSPITAL AND ARE NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE, THE DILATOR OF THE TRAPEASE W/CSI INTRO KIT 55CM SYSTEM WAS DAMAGED SHORTLY AFTER THE PRODUCT WAS TAKEN OUT OF THE BOX. THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE TYPE OF DAMAGE; HOWEVER THE RETURNED DEVICE FOUND THAT THE SHAFT WAS SEPARATED FROM THE HUB. THE PRODUCT WAS NOT CLINICALLY USED, AND OTHER NEW PRODUCT WAS UTILIZED FOR THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE PRODUCT WAS STORED PER LABELING INSTRUCTIONS. EVERY SECTION OF THE DEVICE WAS SECURE IN THE PACKAGE. NOTHING OCCURRED DURING REMOVAL THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PRIOR TO SHIPPING, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 13447691

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L AGILITY 14 GUIDEWIRE (B) (4)