BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 5154320 · Received October 15, 2015

    Report

    Report Number
    1820334-2015-00652
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 18, 2015
    Report Date
    September 22, 2015
    Manufacturer
    COOK INC
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). **** EVENT EVALUATION **** ONE USED PRODUCT WAS RETURNED TO ASSIST IN THE INVESTIGATION. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), DOCUMENTATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL, DRAWINGS AND MANUFACTURING INSTRUCTIONS WAS CONDUCTED DURING THE INVESTIGATION. THE RETURNED PRODUCT HAD A CLEAN SEPARATION AT THE DISTAL END AND DISCOLORATION ON THE PROXIMAL END. THE CLEAN SEPARATION SUGGESTS THAT THE CAUSE OF THIS FAILURE MODE WAS NOT DUE TO SOLELY TO BODY CONTORTION. VISUAL INSPECTION SHOWS NO FRACTURES ALONG THE STENT WHICH COULD WEAKEN IT AND LEAD TO THE FAILURE MODE. THE END USER STATED THAT THE AFFECTED PRODUCT DID NOT COME INTO CONTACT WITH ANOTHER DEVICE THAT COULD LEAD TO THIS FAILURE MODE. REVIEW OF DEVICE HISTORY SHOWS NO NONCONFORMANCE FOR LOT 5000879. THERE IS NO EVIDENCE TO SUGGEST THAT THE AFFECTED PRODUCT WAS NOT MADE WITHIN SPECIFICATIONS. THE IFU CAUTIONS THAT ¿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.¿ IT IS POSSIBLE THAT EXCESS FORCE WAS EXERTED ON THE STENT LEADING TO THE FAILURE MODE. ADDITIONALLY, THE INSTRUCTIONS FOR USE CAUTION THAT ¿INDIVIDUAL VARIATIONS OF INTERACTIONS BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE.¿ THE INVESTIGATION RESULTS ARE INCONCLUSIVE. THE APPROPRIATE INTERNAL PERSONNEL WILL BE NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. BASED ON THE RISK ASSESSMENT PERFORMED, NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE DOCTOR SUCCESSFULLY IMPLANTED A DOUBLE J URETERAL CATHETER IN (B)(6) 2015 ON A (B)(6) MALE PATIENT WHO IS HYDRONEPHROSIS. FIVE MONTHS LATER, ON (B)(6) 2015, THE PATIENT CAME BACK TO THE HOSPITAL FOR A FOLLOW UP. IT WAS AT THIS TIME THE DOCTOR FOUND THE CATHETER WAS BROKEN IN TWO SECTIONS WITHIN THE PATIENT'S BODY. ON (B)(6) 2015, THE PHYSICIAN REMOVED THE STENT WITH ANOTHER MANUFACTURER'S URETEROSCOPE AND A COOK HIWIRE NITINOL HYDROPHILIC WIRE GUIDE. NO HARM TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    THE DOCTOR SUCCESSFULLY IMPLANTED A DOUBLE J URETERAL CATHETER IN (B)(6) 2015 ON A (B)(6) YEAR OLD MALE PATIENT WHO IS HYDRONEPHROSIS. FIVE MONTHS LATER, ON (B)(6) 2015, THE PATIENT CAME BACK TO THE HOSPITAL FOR A FOLLOW UP. IT WAS AT THIS TIME THE DOCTOR FOUND THE CATHETER WAS BROKEN IN TWO SECTIONS WITHIN THE PATIENT'S BODY. ON (B)(6) 2015, THE PHYSICIAN REMOVED THE STENT WITH ANOTHER MANUFACTURER'S URETEROSCOPE AND A COOK HIWIRE NITINOL HYDROPHILIC WIRE GUIDE. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683006 SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO