BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEFF PERCUTANEOUS ACCESS SET

    MDR report key: 8391259 · Received March 5, 2019

    Report

    Report Number
    1820334-2019-00505
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 22, 2019
    Report Date
    April 29, 2019
    Manufacturer
    COOK INC
    Product Code
    KGZ
    UDI-DI
    00827002084261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS RECEIVED ON: 19MAR2019. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A VISUAL INSPECTION, WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE WIRE GUIDE IN A USED AND DAMAGED CONDITION. THE WIRE GUIDE COILS WERE HEAVILY ELONGATED AND THE MANDRIL APPEARS TO HAVE FRACTURED. THE DISTAL END OF COILS ARE NOT ELONGATED AND CONTAIN THE DISTAL SEGMENT OF THE FRACTURED MANDRIL. THE PROXIMAL, ANCHOR, AND DISTAL SOLDERS ARE ALL INTACT AND THERE DOES NOT APPEAR TO BE ANY OTHER SURFACE DAMAGE. THE COIL AND PROXIMAL END MANDRIL OUTER DIAMETERS WERE BOTH MEASURED TO BE WITHIN SPECIFICATION. THE WIRE GUIDE LENGTH WAS DAMAGED OUT OF SPECIFICATION DUE TO THE ELONGATION. SINCE RELEVANT AND MEASUREABLE DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION, THE DEVICE CANNOT BE CONFIRMED TO BE MANUFACTURED OUT OF SPECIFICATION ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED FOR LOT 8991276 AND FOUND NO NONCONFORMANCES. HOWEVER, RELATED WIRE GUIDE SUBASSEMBLY LOTS SHOWED TWO RELATED NONCONFORMANCES, BUT ALL NONCONFORMING PRODUCT WAS SCRAPPED AND QUALITY CONTROL PROCEDURES WERE PERFORMED ON ALL DEVICES IN THE LOT. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS UNDER THIS LOT AND POTENTIALLY RELATED LOTS AT THE TIME OF THIS INVESTIGATION. THE PRODUCT¿S DESIGN HISTORY FILE SHOWS EVIDENCE OF VALIDATIONS IN PLACE TO MEET DESIGN REQUIREMENTS RELATED TO THIS FAILURE MODE. COMPILING THIS INFORMATION, NONCONFORMING PRODUCT IS NOT SUSPECTED IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: UNKNOWN. PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A NEFF PERCUTANEOUS ACCESS SET WAS USED DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) PROCEDURE. THE USER INSERTED THE SHEATH OVER THE WIRE SUCCESSFULLY. HOWEVER, RESISTANCE WAS ENCOUNTERED UPON ATTEMPTING TO REMOVE THE INNER DILATOR AND THE WIRE. NO KINKING OF THE WIRE WAS NOTED AT THIS TIME. THE USER TUGGED AND BOTH THE INNER DILATOR AND WIRE WERE REMOVED, BUT THE WIRE HAD UNRAVELED. THE PROCEDURE CONTINUED AND WAS COMPLETED SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185834 NEFF PERCUTANEOUS ACCESS SET KGZ ACCESSORIES, CATHETER KGZ COOK INC N/A 8991276 00827002084261

    Patients

    Seq Age Sex Outcome Treatment
    1