BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAXX NEPHROSTOMY BALLOON AND SET

    MDR report key: 19945691 · Received August 8, 2024

    Report

    Report Number
    1820334-2024-01060
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    May 20, 2024
    Report Date
    August 8, 2024
    Manufacturer
    COOK INC
    Product Code
    LJE
    UDI-DI
    00827002476493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E3 - OCCUPATION: SURGERY BUYER. G4 ¿ PMA/510(K) #: K181713. INVESTIGATION ¿ EVALUATION. AS REPORTED, THE ULTRAXX NEPHROSTOMY BALLOON AND SET'S SHEATH TIP "CURLED" AND COULD NOT BE INSERTED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETE WITH A NEW DEVICE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, AND INTERVIEWING PERSONNEL WERE CONDUCTED DURING THE INVESTIGATION. ONE SHEATH WAS RETURNED ALONG WITH AN EMPTY MARKETING BOX WITH LABEL. UPON INSPECTION THE TIP OF THE SHEATH WAS FOUND CURLED TO THE INSIDE DIAMETER OF THE SHEATH. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. A COMPLAINT HISTORY SEARCH DID NOT IDENTIFY ANY OTHER COMPLAINTS ASSOCIATED WITH THE REPORTED DEVICE LOT. REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY, QUALITY CONTROL DOCUMENTS, AND DEVICE FAILURE ANALYSIS INDICATES THAT THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATIONS AND DOES NOT SUGGEST OTHER ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE ARE NONCONFORMING. THE IFU WAS REVIEWED AND INCLUDES THE FOLLOWING: WARNINGS: ALWAYS INFLATE THE BALLOON WITH STERILE LIQUID. NEVER INFLATE WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS. DO NOT OVERINFLATE. USING EXCESSIVE PRESSURE TO INFLATE THE BALLOON ON THE DEVICE CAN CAUSE THE BALLOON TO RUPTURE. POTENTIAL ADVERSE EVENTS: COMPLICATIONS THAT MIGHT OCCUR DURING THIS PROCEDURE INCLUDE OVER INFLATION OF THE BALLOON, WHICH COULD RESULT IN TRAUMA TO THE SURROUNDING TISSUE. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE AT THIS TIME. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT 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 TOA DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    AS REPORTED, THE ULTRAXX NEPHROSTOMY BALLOON AND SET'S SHEATH TIP "CURLED" AND COULD NOT BE INSERTED DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETE WITH A NEW DEVICE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562335 ULTRAXX NEPHROSTOMY BALLOON AND SET LJE CATHETER, NEPHROSTOMY LJE COOK INC G47649 15832477 00827002476493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown