BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAIGA 6F GUIDE CATHETER

    MDR report key: 3094042 · Received May 6, 2013

    Report

    Report Number
    1220452-2013-00024
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K083422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING ANLAYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED IN THE CASE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE RETURNED GUIDE CATHETER REVEALED THAT THE TIP OF THE GUIDE CATHETER IS SEVERELY DAMAGED EXHIBITING BROKEN PIECES AND CRACKING OF THE MATERIAL. THE GUIDE CATHETER MATERIAL SHOWS DEGRADATION OF THE DISTAL SEGMENT. THE GUIDE CATHETER BRAID WIRE IS COMPLETELY EXPOSED AND VISIBLE IN THE DISTAL SEGMENT AREA FROM .5MM TO 18MM AND THERE ARE ALSO AREAS WHERE THE LINER MATERIAL THAT HAVE DEGRADATION EVIDENT BY HOLES IN THE LINER MATERIAL. THE DISTAL SEGMENT IS NEARLY COMPLETELY GONE. CLOSER VISUAL EXAMINATION OF THE GUIDE CATHETER DISTAL SEGMENT REVEALED THAT THERE IS MATERIAL PRESENT, BETWEEN 19MM AND 28MM, BUT THE BRAID WIRE IS VISIBLE AS THE HIGH SPOTS OF THE WIRES ARE WORN AWAY. THE RED MATERIAL SECTION APPEARS MOSTLY INTACT BUT THERE ARE SOME SECTIONS WHERE THE BRAID WIRE IS EXPOSED. THERE IS EVIDENCE THAT THE SEGMENT MATERIAL WAS TIGHTLY BONDED TO THE BRAID, HOWEVER THERE IS NO INDICATION THAT THE MATERIAL WAS TORN AWAY FROM THE BRAID WIRE. THE SMOOTH EDGES OF THE SEGMENT MATERIAL REMAINING ON THE BRAID IS CONSISTENT WITH THE SEGMENT MATERIAL BEING DISSOLVED, THIS IS CONSISTENT WITH THE MATERIAL BEING EXPOSED TO OR ATTACKED BY A CHEMICAL SOLVENT, HOWEVER THE EXACT CAUSE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES WITHIN THE MANUFACTURING PROCESS. THE EVENT IS CONFIRMED FOR DAMAGED SHAFT MATERIAL; HOWEVER THE EXACT CAUSE IS UNKNOWN. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THE OUTER JACKET MATERIAL SEPARATED AND MIGHT REMAIN INSIDE THE PATIENT. THE PHYSICIAN OPENED THE GUIDE CATHETER AND NOTICED THAT THE SHAFT OF THE GUIDE CATHETER LOOKED DAMAGED AND THE PHYSICIAN REMOVED SOME MATERIAL FROM THE DISTAL SEGMENT ON THE GUIDE CATHETER SHAFT. THE PHYSICIAN DECIDED TO CONTINUE TO USE THE GUIDE CATHETER. THE PHYSICIAN THEN INSERTED THE GUIDE CATHETER AND ATTEMPTED TO ENGAGE THE GUIDE CATHETER HOWEVER IT WAS VERY DIFFICULT. THE PHYSICIAN REMOVED THE GUIDE CATHETER AND NOTICED THAT THE OUTER JACKET MATERIAL WAS PEELED. THERE WERE NO ISSUES NOTED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196490 TAIGA 6F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTORNIC, INC 0005868051

    Patients

    Seq Age Sex Outcome Treatment
    1