BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 14841448 · Received June 28, 2022

    Report

    Report Number
    1820334-2022-01122
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 13, 2022
    Report Date
    September 7, 2022
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002150034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION: OPERATION ROOM/UROLOGY COORDINATOR. PMA/510K #: K180053. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. EVENT SUMMARY AS REPORTED, WHEN A SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET WAS OPENED, THEY NOTICED THAT ONE OF THE PIGTAILS HAD A SLIT IN THE MATERIAL. THE DEVICE WAS NOT USED ON THE PATIENT. THE TETHER WAS ATTACHED WHEN THE PACKAGE WAS OPENED, BUT THE TECH CUT THE TETHER OFF WITH SCISSORS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADVERSE EVENTS WERE REPORTED DUE TO THE OCCURRENCE. INVESTIGATION - EVALUATION REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS RETURNED FOR INVESTIGATION IN OPENED PACKAGING. A CRACK WAS OBSERVED AT ONE OF THE PIGTAILS ORIGINATING FROM A SIDEPORT. DUE TO DEVICE SYMMETRY, IT COULD NOT BE DETERMINED WHETHER THE CRACK/SLIT WAS ON THE TETHERED OR UNTETHERED END OF THE STENT. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED. NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PRODUCT LOT. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT A CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER A REVIEW OF RISK DOCUMENTATION, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    AS REPORTED, WHEN A SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET WAS OPENED, THEY NOTICED THAT ONE OF THE PIGTAILS HAD A SLIT IN THE MATERIAL. THE DEVICE WAS NOT USED ON THE PATIENT. THE TETHER WAS ATTACHED WHEN THE PACKAGE WAS OPENED, BUT THE TECH CUT THE TETHER OFF WITH SCISSORS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED. NO ADVERSE EVENTS WERE REPORTED DUE TO THE OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018733 SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15003 14647817 00827002150034

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown