BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAXX NEPHROSTOMY BALLOON AND SET

    MDR report key: 8055114 · Received November 9, 2018

    Report

    Report Number
    1820334-2018-03382
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 29, 2018
    Manufacturer
    COOK INC
    Product Code
    LJE
    UDI-DI
    00827002460379
    PMA / PMN Number
    K024050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION RECEIVED: INVESTIGATION EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPH OR IMAGING WAS PROVIDED. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY OBSERVED NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED ONE ADDITIONAL COMPLAINT ASSOCIATED WITH LOT NUMBER 9179613. THE COMPLAINT IS FOR AN UNRELATED FAILURE MODE. THIS DEVICE IS SHIPPED WITH THE INSTRUCTIONS FOR USE (IFU) WHICH CONTAINS THE FOLLOWING RELEVANT PRECAUTIONS: ULTRAXX NEPHROSTOMY BALLOON AND SET. DO NOT EXCEED THE MAXIMUM RATED BURST PRESSURE (LISTED ON LABEL) FOR THIS BALLOON DEVICE. DO NOT PRE-INFLATE THE BALLOON. REFER TO PRODUCT LABEL OR THE INFLATION CHECK VALVE ON THE BALLOON DEVICE FOR APPROPRIATE BALLOON VOLUME. HOW SUPPLIED. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. A DEFINITIVE CONCLUSION REGARDING THE CAUSE OF THE REPORTED FAILURE COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 20NOV2018. AS REPORTED, THE PHYSICIAN ATTEMPTED TO INFLATE TO15 ATM BUT THE BALLOON RUPTURED BEFORE REACHING 15 ATM. THE EXACT PRESSURE IS UNKNOWN WHEN THE BALLOON BURST. THE BALLOON WAS INFLATED WITH WATER AND MEDIA USING THE INFLATION DEVICE CONTAINED IN THE UNBS-6-15-CS KIT. THE BALLOON BURST OCCURRED AT THE TIP OF THE BALLOON. THE DEVICE IS NOT AVAILABLE TO RETURN FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PERCUTANEOUS NEPHROLITHOTOMY (PNL) AND EXCHANGE OF NEPHROSTOMY CATHETER WAS PERFORMED. THE PHYSICIAN INCISED FASCIA AT FIRST AND THEN, ADVANCED A BALLOON CONTAINED IN THE ULTRAXX NEPHROSTOMY BALLOON AND SET OVER A WIRE GUIDE PERCUTANEOUSLY. HE ATTEMPTED TO DILATE THE NEPHROSTOMY FROM 10 FRENCH SIZE TO 18 FRENCH SIZE WITH THE BALLOON TO MAKE A TRACT FOR AN ENDOSCOPE. ALTHOUGH THE BALLOON DID NOT TOUCH A RENAL STONE, IT WAS RUPTURED DURING INFLATION. HE USED A FASCIAL DILATOR (MADE OF METAL) INSTEAD AND THE DILATION OF THE FISTULA COULD BE COMPLETED SUCCESSFULLY. AFTER THAT, PNL WAS PERFORMED, CATHETER WAS EXCHANGED AS PLANNED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894901 ULTRAXX NEPHROSTOMY BALLOON AND SET LJE CATHETER, NEPHROSTOMY LJE COOK INC 9179613 00827002460379

    Patients

    Seq Age Sex Outcome Treatment
    1