BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1081978 · Received July 22, 2008

    Report

    Report Number
    9616099-2008-01818
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2008-01819. THE COMPLAINT RECEIVED STATES THAT THREE OUTBACK LTD RE-ENTRY CATHETERS MALFUNCTIONED DURING AN INTERVENTIONAL PROCEDURE TO A CTO (CHRONIC TOTAL OCCLUSION) LOCATED IN THE MID-SFA (SUPERFICIAL FEMORAL ARTERY). THE PATIENT WAS MALE OF UNKNOWN AGE AND MEDICAL HISTORY. THE TARGET LESION WAS THE MID-SFA DESCRIBED AS MODERATELY CALCIFIED WITH 100% STENOSIS. TWO UNIDENTIFIED OUTBACK LTD CATHETERS WERE EACH SUCCESSFULLY TRACKED, FROM A CONTRALATERAL APPROACH, INTO THE TARGET AREA USING A STABILIZER PLUS WIRE, WHICH IS A RECOMMENDED WIRE. BOTH CATHETERS ACTUATED WITHOUT DIFFICULTY, HOWEVER, BOTH DEVICES FAILED TO RETRACT THE NEEDLE. A THIRD OUTBACK LTD CATHETER WAS INSERTED, USING A CONTRALATERAL APPROACH AND WHILE ATTEMPTING TO CROSS THE HORN, THE NOSE CONE FRACTURED AND WAS DANGLING. THE CATHETER WAS RETRIEVED WITHOUT ANY DIFFICULTIES, AND NO PORTION WAS RETAINED WITHIN THE PATIENT. THERE WERE NO REPORTED INJURIES FOR THE PATIENT. ON THE FIRST TWO CATHETERS THAT WERE USED, NO STERILE LOT NUMBERS WERE AVAILABLE; THEREFORE, A DEVICE HISTORY RECORD (DHR) COULD BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE THIRD CATHETER AND IT SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. EXTENDED DHR REVIEW WAS PERFORMED FOR OUTER SHAFT & NOSECONE SUBASSEMBLY LOT NUMBERS 13395305, 13385457, 13385459, 13395308, 13382303 AND NO ANOMALIES WERE FOUND. THE THREE DEVICES WERE UNAVAILABLE FOR ANALYSIS; THEREFORE, THE REPORTED COMPLAINT OF RETRACTION DIFFICULTY WAS NOT CONFIRMED. HOWEVER, THE FAILURE MODE HAS BEEN IDENTIFIED IN THE OUTBACK CATHETER FAMILY, POSSIBLY RELATING TO MANUFACTURING ISSUES. DPRA HAS BEEN OPENED TO ADDRESS THE ISSUE OF ROOT CAUSE FOR THIS FAILURE MODE IN THE OUTBACK CATHETER FAMILY.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A MODERATELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. IT WAS NOTED THAT DURING THE PROCEDURE, TWO OUTBACK RE-ENTRY CATHETERS WERE USED IN THE PT AND THE NEEDLE WOULD NOT RETRACT AT ALL. DUE TO THIS, THE PHYSICIAN HAD TO USE A THIRD OUTBACK CATHETER AND WHILE ATTEMPTING TO CROSS THE HORN, DURING A CONTRALATERAL APPROACH, THE NOSE CONE BROKE AND WAS HANGING BY A SMALL PIECE. THE CATHETER WAS RETRIEVED WITHOUT ANY DIFFICULTIES. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEM (DQY) DQY CORDIS DE MEXICO NA 13395460

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK