BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3072806 · Received April 23, 2013

    Report

    Report Number
    1016427-2013-00051
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 11, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE (WHICH IS INDICATED AS "OTHER" UNDER SECTION H3 CODE). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(6) THERE WAS CAPTURE DIFFICULTY WITH THE ANGIOGUARD EMBOLIC PROTECTION DEVICE (EPD). THE BASKET WOULD NOT COMPLETELY CLOSE, BUT COLLAPSED ENOUGH TO SUCCESSFULLY REMOVE WITHOUT INJURY TO THE PATIENT. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY (R6) DESCRIBED AS ULCERATED, MILDLY CALCIFIED AND MILDLY TORTUOUS WITH AN 88% STENOSIS. AN ANGIOGUARD WAS DEPLOYED DISTAL TO THE LESION, THE LESION WAS PRE-DILATED AND A PRECISE STENT WAS SUCCESSFULLY DEPLOYED. THE CAPTURE SHEATH WAS ADVANCED TO THE LESION WHILE THE FILTER WIRE WAS IN A FIXED POSITION. THE PHYSICIAN WAS UNABLE TO LINE UP THE MARKER BAND OF THE CAPTURE SHEATH WITH THE PROXIMAL FILTER BASKET MARKER BAND. WHEN ATTEMPTING TO CAPTURE THE ANGIOGUARD FILTER BASKET WOULD NOT COMPLETELY RETURN INTO THE CAPTURE SHEATH DESPITE TENSION THAT WAS ADEQUATE ENOUGH TO THE BOW WIRE. THE FILTER BASKET PARTIALLY COLLAPSED INTO THE CAPTURE SHEATH AND WAS REMOVED PARTIALLY CLOSED. THERE WAS NO DEBRIS FOUND IN THE FILTER BASKET UPON INSPECTION AFTER REMOVAL. THE PHYSICIAN DID NOT FEEL THAT ANY DEBRIS FROM THE FILTER BASKET ESCAPED DURING WITHDRAWAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE SAPPHIRE REGISTRY THERE WAS CAPTURE DIFFICULTY WITH THE ANGIOGUARD EMBOLIC PROTECTION DEVICE (EPD). THE BASKET WOULD NOT COMPLETELY CLOSE, BUT COLLAPSED ENOUGH TO SUCCESSFULLY REMOVE WITHOUT INJURY TO THE PATIENT. THE PATIENT IS AN (B)(6) FEMALE. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY (R6). THE VESSEL WAS DESCRIBED AS ULCERATED, MILDLY CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 88%. AN ANGIOGUARD ((B)(4)/ LOT 70412488) EPD WAS DEPLOYED DISTAL TO THE LESION AND THE LESION WAS PRE-DILATED. A PRECISE STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. THE CAPTURE SHEATH WAS ADVANCED TO THE LESION WHILE THE FILTER WIRE WAS IN A FIXED POSITION. THE PHYSICIAN WAS UNABLE TO LINE UP THE MARKER BAND OF THE CAPTURE SHEATH WITH THE PROXIMAL FILTER BASKET MARKER BAND. WHEN ATTEMPTING TO CAPTURE THE ANGIOGUARD FILTER BASKET WOULD NOT COMPLETELY RETURN INTO RETRIEVAL CATHETER DESPITE TENSION ADEQUATE TO BOW WIRE. THE FILTER BASKET PARTIALLY COLLAPSED INTO THE CAPTURE SHEATH AND WAS REMOVED PARTIALLY CLOSED. THERE WAS NO DEBRIS FOUND IN THE FILTER BASKET UPON INSPECTION AFTER REMOVAL. THE PHYSICIAN DID NOT FEEL THAT ANY DEBRIS FROM THE FILTER BASKET ESCAPED DURING WITHDRAWAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173636 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70412488

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR PRECISE STENT