BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 7473065 · Received April 30, 2018

    Report

    Report Number
    1820334-2018-01189
    Event Type
    Injury
    Date Received
    April 30, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 18, 2018
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002151208
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: PREAMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A VISUAL EXAMINATION OF THE RETURNED STENT WAS CONDUCTED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, QUALITY CONTROL DATA AND SPECIFICATIONS WAS ALSO PERFORMED. ONE USED 6FR 24CM STENT (133724) WAS RECEIVED. DEVICE WAS RETURNED IN USED CONDITION AND IN TWO SEGMENTS. THE PROXIMAL COIL SEGMENT WITH 1.3CM OF STENT BODY IS STILL ATTACHED. IT IS SEVERED AT 23CM FROM THE EDGE OF THE DISTAL COIL. THE DISTAL COIL SEGMENT MEASURED 23CM FROM THE EDGE OF THE COIL TO THE POINT OF SEPARATION. THE TOTAL LENGTH OF STENT SEGMENTS RETURNED MEASURED 24.3CM FROM COIL TO COIL. THE EDGES AT THE POINT OF SEPARATION ARE UNEVEN AND JAGGED. THE SEPARATION WAS NOTED TO OCCUR AT A SIDE PORT. THE DISTAL COIL SHOWED EXTREME DEGRADATION ON THE MATERIAL SURFACE. THE RECOMMENDED INDWELLING TIME FOR BLACK SILICONE STENTS IS 12 MONTHS. IT WAS REPORTED THE STENT WAS INITIALLY PLACED ON (B)(6) 2017 AND THEN REMOVED (B)(6) 2018. THE INDWELLING TIME WAS ALMOST 6 MONTHS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE FOUND RELATED TO THE REPORTED ISSUE. A REVIEW OF COMPLAINT HISTORY SHOWS THIS COMPLAINT TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 7636526. THE INSTRUCTIONS FOR USE (IFU) STATES, ¿DO NOT FORCE SET COMPONENTS DURING PLACEMENT, REPLACEMENT, OR REMOVAL. CAREFULLY REMOVE THE SET COMPONENTS IF ANY RESISTANCE IS ENCOUNTERED.¿ THERE IS NO MENTION OF DEVICE PLACEMENT AND HANDLING. PER THE IFU, ¿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.¿ STENT FRACTURE IS A KNOWN INHERENT RISK OF URETERAL STENT PLACEMENT. THE IFU ADVISES, ¿INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE. THE PROBABLE CAUSE OF THIS EVENT ARE DISEASE PROGRESSION AND HUMAN ANATOMY RELATED BASED ON THE CLINICAL ASSESSMENT OF THE REPORTED DESCRIPTION OF THE EVENT. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET BROKE AT THE DISTAL END AS THE DOCTOR WAS TRYING TO PULL IT OUT DURING A LEFT URETEROSCOPY WITH LASER LITHOTRIPSY AND STENT REMOVAL PROCEDURE. THE STENT WAS ENCRUSTED AT THE PROXIMAL END AND A STONE HAD FORMED. DUE TO THE APPLIED PRESSURE AND THE SIZE OF THE STONE, THE DOCTOR WAS UNABLE TO PULL THE STENT OUT AND THEREFORE IT WAS UNABLE TO WITHSTAND THE PRESSURE AND SNAPPED. THE DOCTOR WAS ABLE TO FINISH THE CASE AND NO ADDITIONAL PROCEDURES WERE REQUIRED. THE PATIENT WAS SAFE AND ANOTHER STENT WAS PLACED AFTER THE STONE BURDEN WAS REMOVED. THE PROXIMAL END OF THE STENT WAS REMOVED FROM THE RENAL PELVIS WITH THREE PRONGED GRASPER THAT FIT THROUGH A URETEROSCOPE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315326 FILIFORM DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15120 00827002151208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention