BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 2142417 · Received June 28, 2011

    Report

    Report Number
    1016427-2011-00065
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 5, 2011
    Report Date
    July 29, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN NOTICED THAT THE MICRO-MESH WAS PULLED AWAY FROM THE 7MM ANGIOGUARD BASKET ON ONE SIDE OF THE DEVICE AFTER REMOVAL FROM THE PATIENT AND SHEATH. THE PHYSICIAN SAID THEY DID NOT FEEL ANY TENSION OR DIFFICULTY FROM THE DEVICE WHILE REMOVING IT FROM THE PATIENT. THE DEVICE WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO IFU. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE. THE TARGET LESION WAS THE INTERNAL CAROTID ARTERY AND WAS LOCATED AT THE CAROTID BIFURCATION. THE VESSEL WAS 7MM IN DIAMETER AND THE ANGIOGUARD WAS NOT SIZED LARGER THAN THE VESSEL AS INSTRUCTED IN THE IFU. THE DEVICE DID NOT PASS THROUGH ANY ACUTE BENDS AND NO UNUSUAL FORCE WAS USED DURING THE PROCEDURE. THE FILTER BASKET DID COLLAPSE INTO THE CAPTURE SHEATH AS EVIDENCED BY A REDUCTION IN FILTER BASKET DIAMETER SHOWN BY THE RADIOPAQUE STRUT MARKERS. THERE WAS NO DIFFICULTY CAPTURING THE FILTER BASKET INTO THE CAPTURE SHEATH. THERE WAS NO DEBRIS IN THE FILTER BASKET AFTER REMOVAL. THERE WAS NO REPORTED PATIENT INJURY. NOTE: LAKE REGION LOT NUMBER 02414299 WHICH IS CORDIS LOT NUMBER 71109509. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 02414299. THIS PACKAGING LOT CONTAINED 94 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON (B)(6) 2009. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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 EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN NOTICED THAT THE MICRO-MESH WAS PULLED AWAY FROM THE 7MM ANGIOGUARD BASKET ON ONE SIDE OF THE DEVICE AFTER REMOVAL FROM THE PATIENT AND SHEATH. THE PHYSICIAN SAID THEY DID NOT FEEL ANY TENSION OR DIFFICULTY FROM THE DEVICE WHILE REMOVING IT FROM THE PATIENT. PICTURES ARE ATTACHED AT THE SERVICE REQUEST. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE IFU. IT WAS INSPECTED AND PREPPED ACCORDING TO IFU. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE. THE TARGET LESION WAS THE INTERNAL CAROTID ARTERY. THE LESION WAS LOCATED AT A CAROTID BIFURCATION. THE VESSEL DIAMETER WAS 7MM. THE ANGIOGUARD WAS NOT SIZED LARGER THAN THE VESSEL AS INSTRUCTED IN THE IFU. THE DEVICE DID NOT PASS THROUGH ANY ACUTE BENDS. NO UNUSUAL FORCE WAS USED DURING THE PROCEDURE. THE FILTER BASKET DID COLLAPSE INTO THE CAPTURE SHEATH AS EVIDENCED BY A REDUCTION IN FILTER BASKET DIAMETER SHOWN BY THE RADIOPAQUE STRUT MARKERS. THERE WAS NO DIFFICULTY CAPTURING THE FILTER BASKET INTO THE CAPTURE SHEATH. THERE WAS NO DEBRIS IN THE FILTER BASKET AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71109509

    Patients

    Seq Age Sex Outcome Treatment
    1