BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 7828076 · Received August 29, 2018

    Report

    Report Number
    1820334-2018-02621
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 17, 2018
    Report Date
    October 12, 2018
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002151239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6 ¿ EVALUATION METHODS CODE: INCOMPLETE DEVICE RETURNED (4116). INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE 7FR 22CM BLACK SILICONE STENT WAS RECEIVED. THE STENT WAS RETURNED WITHOUT THE PACKAGE OR LABEL TO CONFIRM THE LOT NUMBER OF THE SET. THE POSITIONER AND WIRE GUIDE WERE NOT RETURNED. VISUAL EXAMINATION OF THE RETURNED STENT CONFIRMED THE TETHER WAS NOT IN THE STENT OR RETURNED WITH THE STENT. UNDER MAGNIFICATION A TEAR IN THE PROXIMAL COIL WAS OBSERVED. THE TEAR STARTS AT THE FIRST SIDE PORT, LOCATED 5MM FROM THE END OF THE COIL, AND CONTINUES THROUGH THE END OF THE COIL. THE DEVICE HISTORY RECORD REVIEW SHOWED THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED FAILURE. A SEARCH OF COMPLAINT RECORDS REVEALED THIS IS THE ONLY COMPLAINT FOR COMPLAINT DEVICE LOT NUMBER 8183360. A REVIEW OF THE QUALITY CONTROL INSTRUCTIONS IDENTIFIED THE PRODUCT IS INSPECTED BEFORE SHIPMENT. THE DEVICE WAS RETURNED WITHOUT THE MANUFACTURING INSTRUCTION SPECIFIED TETHER. THE ¿CUT/SLIT¿ THAT THE CUSTOMER REPORTED WAS CONFIRMED. THE CUT STARTS AT THE FIRST SIDE FROM THE TIP OF THE PROXIMAL END OF THE STENT. DUE TO THE TETHER BEING REMOVED FROM THE COIL AND THE APPEARANCE OF THE TEAR IN THE COIL, IT IS LIKELY THE STENT WAS TORN DURING REMOVAL OF THE TETHER. THE LIKELY CAUSE OF THE COMPLAINT; THE STENT WAS DAMAGED WHEN THE TETHER WAS REMOVED; CAUSE TRACED TO USER; UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. A QUALITY ENGINEER RISK ASSESSMENT CONCLUDED NO RISK REDUCTION ACTIVITIES ARE REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE 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

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WHILE PREPPING FOR THE PROCEDURE WHEN THEY TOOK THE FILIFORM DOUBLE PIGTAIL URETERAL STENT OUT OF THE PACKAGE IT WAS NOTED THE END WAS SLIT/CUT. THE END USER DEPARTMENT DID NOT PROVIDE ANY FURTHER INFORMATION AS THERE HAD NOT BEEN ANY PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666558 FILIFORM DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15123 8183360 00827002151239

    Patients

    Seq Age Sex Outcome Treatment
    1