BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 6587608 · Received May 24, 2017

    Report

    Report Number
    1820334-2017-01054
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Date of Event
    May 1, 2017
    Report Date
    February 1, 2018
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002151284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, QUALITY CONTROL DATA AND SPECIFICATIONS WAS PERFORMED. A VISUAL EXAMINATION OF THE RETURNED STENT WAS ALSO CONDUCTED. THE STENT WAS RETURNED WITH A PEEL OFF LABEL CONFIRMING THE RPN 133824 AND LABEL LOT NUMBER 7679519. STENT AND TETHER WAS RETURNED IN TWO SEPARATE PIECES. TETHER HAS BEEN PULLED OUT OF THE STENT. THE STENT PROXIMAL COIL WAS TORN STARTING AT THE LAST SIDE PORT AND CONTINUED THROUGH THE END OF THE STENT. THE TETHER WAS RETURNED IN ONE CONTINUOUS UNBROKEN PIECE. THE TETHER HAS BEEN REMOVED FROM THE STENT; EXCESSIVE PRESSURE APPLIED TO THE TETHER DURING REMOVAL HAS TORN THE STENT COIL. THERE IS NO EVIDENCE OF ANY MANUFACTURING ANOMALIES THAT WOULD CONTRIBUTE TO THIS EVENT. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO OTHER NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY FOR THIS PRODUCT/LOT NUMBER COMBINATION DID NOT REVEAL ANY OTHER COMPLAINTS TO BE ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BASED ON THE INFORMATION PROVIDED AND RETURNED DEVICE ANALYSIS, THE DEFINITIVE ROOT CAUSE IS RELATED TO PRODUCT USE AND APPLYING EXCESSIVE PRESSURE ON THE DEVICE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN INTENDED CYSTOSCOPY WITH STENT EXCHANGE PROCEDURE ON A PATIENT, THE CUSTOMER FOUND THAT THE TETHER RIPPED FREE FROM THE DISTAL END OF THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER FILIFORM DOUBLE PIGTAIL URETERAL STENT SET. 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
    370946 FILIFORM DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC N/A 00827002151284

    Patients

    Seq Age Sex Outcome Treatment
    1