BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE AMPLATZ URETERAL STENT SET

    MDR report key: 10524496 · Received September 11, 2020

    Report

    Report Number
    1820334-2020-01669
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    June 19, 2020
    Report Date
    September 11, 2020
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002097094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K171603. INVESTIGATION EVALUATION: IT WAS REPORTED TO COOK THAT THE BLACK INTRODUCER WITHIN AN ULTRATHANE AMPLATZ URETERAL STENT SET COULD NOT BE ADVANCED TO MEET THE STENT. THIS INCIDENT WAS REPORTED BY DORSET COUNTY HOSPITAL IN THE UNITED KINGDOM. NO ADVERSE EFFECTS WERE REPORTED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST, AND DIMENSIONAL VERIFICATION, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT RETURNED THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. THE URETERAL STENT SET WAS RETURNED IN AN OPENED, PREPPED AND DAMAGED CONDITION. A VISUAL EXAMINATION DISCOVERED THE STENT POSITIONER NEAR THE DISTAL END WAS WRINKLED THUS PREVENTING THE AMPLATZ URETERAL STENT FORM PROPERLY ADVANCING. ADDITIONALLY, THE POSITIONING STRING WAS MISSING FROM THE AMPLATZ URETERAL STENT. DURING TABLETOP TESTING, THE STENT POSITIONER WAS ABLE TO BE FLUSHED WITHOUT DIFFICULTY. ALL DIMENSIONS DEEMED RELEVANT TO THE FAILURE MODE WERE ANALYZED AND CONFIRMED THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE: ¿HOLDING THE LOADING STYLET BEYOND THE TAPERED END OF THE URETERAL STENT INTRODUCER, LIGHTLY GRASP THE STENT ITSELF AND BEGIN ADVANCING THE NON-TAPERED PROXIMAL END OF THE STENT ONTO THE PRE-ASSEMBLED STENT INTRODUCER. ADVANCE THE STENT UNTIL ITS PROXIMAL END ALIGNS WITH AND COVERS THE RADIOPAQUE MARKER ON THE STENT INTRODUCER CATHETER. LOOSEN THE TUOHY-BORST ADAPTER AND POSITION THE DISTAL END OF THE STENT POSITIONER SO THAT IT ABUTS THE PROXIMAL END OF THE URETERAL STENT AT THE RADIOPAQUE MARKER.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION. THE DHR FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS RECORDS NO RELEVANT NONCONFORMANCE'S. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. AT THIS TIME, COOK CONCLUDED THAT NO NONCONFORMING PRODUCTS FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED A COMPONENT FAILURE WITHOUT MANUFACTURING OR DESIGN DEFICIENCY CONTRIBUTED TO THIS INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE AMPLATZ URETERAL STENT SET FOR A URETERIC STENT INSERTION PROCEDURE. DURING THE PROCEDURE, THE OPERATOR STATED THEY COULD NOT FLUSH THE DEVICE AND THE BLACK INTRODUCER WOULD NOT MOVE DOWN TO MEET THE STENT. 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
    989140 ULTRATHANE AMPLATZ URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC N/A 9921278 00827002097094

    Patients

    Seq Age Sex Outcome Treatment
    1