BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 9537779 · Received January 2, 2020

    Report

    Report Number
    1820334-2020-00007
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 7, 2020
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF DRAWINGS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. TWO DEVICES WERE RETURNED FOR INVESTIGATION. VISUAL EXAMINATION CONFIRMED TWO STENTS, ONE POSITIONER AND ONE WIRE GUIDE WERE RECEIVED. COMPONENTS WERE RETURNED IN ONE PACKAGING TRAY. BOTH STENTS ARE IN USED CONDITION AND HAVE BEEN SEVERED INTO TWO SEGMENTS. STENT A ¿ SEVERED 15.4CM FROM THE DISTAL COIL. THIS SEGMENT WAS WIRED WITH THE RETURNED .038¿ WIRE GUIDE THROUGH THE DISTAL COIL. THE STENT WAS OCCLUDED 2CM FROM THE SEVERED END. THE POINT OF SEPARATION OCCURRED AT A SIDE PORT. THE WIDTH OF BOTH COILS IS 16-17MM. PROXIMAL SEGMENT MEASURED 9.9CM FROM THE COIL. POINT OF SEPARATION OCCURRED AT A SIDEPORT. UNDER MAGNIFICATION A DEEP GOUGE WAS VISIBLE ON THE OUTSIDE WALL OF THE TUBING LEADING TO THE POINT OF SEPARATION. DRIED DEBRIS WAS VISIBLE ON THE OUTSIDE AND INSIDE THE STENT. THE PROXIMAL SEGMENT WAS OCCLUDED 3MM FROM THE SEVERED END. BOTH SEGMENTS HAD MATING FRACTURES INDICATING NO MISSING PIECES, TOTAL LENGTH OF THE STENT 25.3CM. DAMAGE TO THE OUTSIDE WALL ON THIS STENT APPEARED TO BE USE RELATED. STENT B WAS RETURNED IN A ZIP LOCK BAG MARKED ¿NORMAL¿. THE LENGTH OF THE STENT FROM THE DISTAL COIL MEASURED 26CM. THE WIDTH OF THE COIL MEASURED 18MM, PROXIMAL COIL WAS NOT RETURNED. STENT HAS A CLEAN STRAIGHT CUT BELOW THE LAST INK BAND ON THE PROXIMAL END, INDICATING AN INTENTIONAL CUT WITH A SHARP INSTRUMENT. THE STENT WAS WIRED AND WAS FOUND TO NOT BE OCCLUDED. NO MANUFACTURING ANOMALIES WERE NOTED ON THIS DEVICE. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. TWO STENTS WERE RETURNED. FROM THE PROVIDED INFORMATION, ONE STENT BROKE DURING REMOVAL, THE OTHER STENT WAS REMOVED WITHOUT ISSUE FROM THE OTHER URETER. THE STENT THAT BROKE DURING REMOVAL WAS FOUND TO HAVE A DEEP GOUGE VISIBLE ON THE OUTSIDE WALL OF THE TUBING LEADING TO THE POINT OF SEPARATION. THE GOUGE APPEARS TO HAVE BEEN CAUSED FROM THE STENT SCRAPPING AGAINST AN UNKNOWN DEVICE. IT COULD NOT BE DETERMINED IF THE GOUGE OCCURRED BEFORE OR AFTER THE STENT SEPARATED. IMPROPER HANDLING CAN SERIOUSLY WEAKEN THE STENT. ACUTE BENDING OR OVERSTRESSING DURING PLACEMENT MAY RESULT IN SUBSEQUENT SEPARATION OF THE STENT AT THE POINT OF STRESS AFTER A PROLONGED INDWELLING PERIOD. A DEFINITIVE CAUSE OF STENT SEPARATION WAS NOT DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE 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 HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510K #: K172017. 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, DURING A URETERORENOSCOPY TO REPLACE A FILIFORM DOUBLE PIGTAIL URETERAL STENT, THAT ONE STENT WAS BROKEN IN THE MIDDLE. THE PATIENT WAS UNDERGOING A BILATERAL STENT REPLACEMENT. THE USER WAS ATTEMPTING TO REPLACE THE TWO OLD STENTS AND DISCOVERED THAT ONE OF THEM WAS BROKEN IN THE "MIDDLE PART". THE PHYSICIAN REMOVED THE BROKEN STENT AND PLACED ANOTHER NEW SAME TYPE STENT INTO THE PATIENT TO COMPLETE THE PROCEDURE. THE REMOVAL AND REPLACEMENT OF THE OTHER SIDE'S STENT WAS NORMAL. THE PHYSICIAN NOTED THAT THEY CUT THE PIGTAIL OF THIS STENT FOR WIRE GUIDE PLACEMENT. NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184 FILIFORM DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR