BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1111897 · Received August 12, 2008

    Report

    Report Number
    1016427-2008-00214
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 16, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PT HAD PARALYSIS ON RIGHT HAND AND FEET. THE REPORT RECEIVED INDICATED THAT THE PT UNDERWENT CAROTID ARTERY STENTING; DURING THE PROCEDURE, THE DELIVERY OF THE ANGIOGUARD AND THE PRECISE STENT PLACEMENT WERE SUCCESSFUL. POST-DILATATION WAS CONDUCTED AT 10 ATMOSPHERES; AFTER POST-DILATATION, THE PT HAD PARALYSIS ON THE RIGHT HAND AND FEET. THEREFORE, THE PHYSICIAN ADMINISTERED HYPERBARIC OXYGENATION (HBO) TO THE PT. AT THE TIME OF THE REPORT, THE PT WAS STILL UNDER TREATMENT IN THE HOSPITAL; HOWEVER, THE HAND PARALYSIS WAS RECOVERING. REFERRING TO THE ANGIOGUARD CAPTURE SYSTEM, "THE PHYSICIAN THINKS THAT THE FILTER BASKET COULDN'T CAPTURE DEBRIS COMPLETELY, WHICH CAUSED THE SYMPTOMS." HOWEVER, THERE WERE NO ANOMALIES OR A SPECIFIC PRODUCT MALFUNCTION IDENTIFIED ON THE DEVICE. THE TARGET LESION WAS IN THE LEFT INTERNAL CAROTID ARTERY, THE VESSEL PRESENTED MILD CALCIFICATION WITHOUT TORTUOSITY AND WITH A 74%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70508516

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R PATIENT'S MEDICATION INCLUDED HEPARIN ON THE| AND 5X10MM POST DILITATION BALLOON| PRECISE STENT| OPERATION DATE AND ASPIRIN & CLOPIDOGREL FOR 60| DAYS BEFORE OPERATION. DEVICES USED:| CATHETER (UNK MANUFACTURER).