BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CATH. ACCESS. KIT (LCAK)

    MDR report key: 5394043 · Received January 27, 2016

    Report

    Report Number
    9612007-2016-00004
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Date of Event
    January 5, 2016
    Report Date
    January 5, 2016
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K032817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2016. THE INVESTIGATION INCLUDED: EVALUATION OF ACTUAL DEVICE REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. THE GUIDEWIRE ONLY WAS RECEIVED, UNCOILED AND PRESENTING SEVERAL BENTS. THE GUIDEWIRE WAS SENT TO THE SUPPLIER FOR FURTHER ANALYSIS: THE GUIDEWIRE PRESENTED EXTENSIVE BEND DAMAGE OF VARYING SEVERITY AND FREQUENCY, STRETCHED COIL DAMAGE, AND A FRACTURE OF THE CORE WIRE WITH INDICATIONS OF A DUCTILE, TENSILE OVERLOAD NEAR THE PROXIMAL END. THE DISTAL ASPECT OF THE COIL WIRE FRACTURE PRESENTS INDICATIONS OF DUCTILE TENSILE OVERLOAD WITH TORSIONAL LOADING. THE SPECIMEN ALSO PRESENTS OFFSET/MIS-ALIGNED COIL WRAPS 4.15 TO 4.50CM FROM THE DISTAL TIP, WHICH ALONG WITH THE SPIRAL BENDS, SUGGESTS TORSIONAL LOADING. THE PROXIMAL COIL-TO-CORE WIRE JOINT AND AN INDETERMINATE LENGTH OF OUTER COIL WRAPS ARE MISSING THE DEVICE HISTORY RECORDS OF THE LCAK REF (B)(4) LOT 190788 AND OF THE GUIDEWIRE LOT 10479737 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. THE BATCH WAS MANUFACTURED IN MAY 2015 AND INCLUDED 100 LCAK. NO SIMILAR COMPLAINT WAS RECEIVED FOR A PRODUCT FROM THIS BATCH. A REVIEW OF COMPLAINTS HISTORY FOR THE LAST 3 YEARS INDICATED THE RATE OF COMPLAINT REPORTS FOR DIFFICULTY TO REMOVE THE GUIDEWIRE IS 0.01%. THE COMPLAINT IS VERIFIED. SUCH UNCOILED ASPECT OF THE GUIDEWIRE IS EXPLAINED BY THE CUT OF THE COIL-TO-CORE WIRE JOINT, THE EXACT ROOT CAUSE OF THE CUT IS UNDETERMINED. INVESTIGATION CONCLUDED CLINICAL/PROCEDURAL FACTORS APPEAR TO HAVE IMPACTED ON THE EVENT AS REPORTED. ONE HYPOTHESIS IS THAT THE CUT MAY BE RELATED TO THE TUOHY NEEDLE DURING INSERTION, DAMAGING BOTH THE CATHETER AND THE GUIDEWIRE (BUT THE CATHETER WAS NOT RETURNED FOR INVESTIGATION).

    Description of Event or Problem · 1

    WHEN REMOVING THE CATHETER, THE WIRE (WHICH CONSISTS OF SEVERAL BRAIDED WIRES) BROKE DOWN INTO INDIVIDUAL PARTS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2016 WITH THE FOLLOWING: THE (B)(6) YEAR OLD MALE PATIENT WAS NOT INJURED. THE SURGERY TIME TOOK 15 MINUTES LONGER BECAUSE THEY USED A SECOND CATHETER. THE SECOND CATHETER WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53800 LUMBAR CATH. ACCESS. KIT (LCAK) EXTERNAL DRAINAGE ACCESSORIES JXG INTEGRA NEUROSCICENCS IMPLANTS SA 0000000190788

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR