BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDTRANSIT MICROCATHETERS

    MDR report key: 1230402 · Received November 7, 2008

    Report

    Report Number
    1058196-2008-00266
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K972518
    Removal / Correction Number
    10/15/2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT PRIOR TO INSERTING, THE MICROCATHETER WAS NOT DAMAGED, AND THE PRODUCT WAS PREP PER (IFU) INSTRUCTION FOR USE. THE MICROCATHETER WAS NOT RE-SHAPED. CONSTANT FLUSH WAS UTILIZED DURING INSERTION WITH THE GUIDEWIRE, AND THERE WAS NO RESISTANCE/FRICTION NOTICED BETWEEN THE TWO DEVICES. AFTER THE MICROCATHETER WAS INSERTED THROUGH THE TUOHY, NO RESISTANCE WAS NOTICED BETWEEN THE MICROCATHETER AND GUIDE WIRE. DURING DELIVERY, THE GUIDEWIRE MOVED SMOOTHLY THROUGH THE INNER LUMEN OF THE MICROCATHETER. BESIDES THE REPORTED EVENT WITH THE MICROCATHETER, NO OTHER ISSUES WERE NOTED WITH THE MICROCATHETER. AFTER REMOVAL, THE GUIDE WIRE WAS NOT DAMAGED. THE FIRST GUIDE WIRE USED WAS ASTATO, AND THEN CHANGED TO TREASURE. AFTER THAT WHEN THE MICROCATHETER WAS REMOVED ONCE FROM THE PATIENT AND WAS ATTEMPTED TO INSERT AGAIN, THE PHYSICIAN FOUND THE DAMAGE ON THE CATHETER. ANY DAMAGE OR ABNORMALITY WAS NOT NOTED ON THE GUIDE WIRE USED. NO FURTHER INFORMATION WAS AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED TO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13264221 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DEVICE HISTORY RECORD WAS REVIEW CONFIRMED NO ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO UNDERGO A (PTA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF A (CTO) COMPLETE TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY. THE TARGET VESSEL WAS MILDLY CALCIFIED, NOT TORTUOUS, AND THE RATE OF STENOSIS WAS 100%. THE TRANSIT2 (601-210, COMPLAINT PRODUCT) WAS USED FOR SUPPORTING THE GUIDE WIRE (ASTATO AND TREASURE). DURING DELIVERY, BRAID MATERIAL PART OF THE MICRO CATHETER PROTRUDED FROM THE DISTAL TIP. ANOTHER NEW MICRO CATHETER (DETAIL UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDTRANSIT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 13264221

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR GUIDE WIRE: ASTATO| TREASURE| STENT: SMART CONTROL X4| SHEATH: TERUMO 6FR