BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAUTERINE ACCESS BALLOON CATHETER

    MDR report key: 10988090 · Received December 10, 2020

    Report

    Report Number
    1820334-2020-02277
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 27, 2020
    Report Date
    February 17, 2021
    Manufacturer
    COOK INC
    Product Code
    LKF
    UDI-DI
    00827002303973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: AS REPORTED, DURING A HYSTEROSALPINGOGRAM(HSG) PROCEDURE USING A INTRAUTERINE ACCESS BALLOON CATHETER, CONTRAST MEDIUM WAS LEAKING FROM THE FLO-CHECK VALVE. AFTER THE PROCEDURE, THE 2ML INFLATED BALLOON COULD NOT BE DEFLATED. THE USER USED THE CATHETER STYLET TO DEPRESS THE INFLATION PORT VALVE. THE SALINE THEN STARTED FLOWING OUT AND THE BALLOON DEFLATED. THE CATHETER WAS THEN REMOVED FROM THE PATIENT. NO ADVERSE EVENTS WERE REPORTED. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), THE INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA. ONE INTRAUTERINE ACCESS BALLOON CATHETER WAS RETURNED FOR INVESTIGATION IN A USED CONDITION. A FUNCTION TEST WAS PERFORMED BY INFLATING THE BALLOON WITH TAP WATER. NO LEAKAGE WAS OBSERVED DURING INFLATION. THE BALLOON WAS ABLE TO BE INFLATED AT THE 2ML INFLATION PORT, BUT THE BALLOON COULD NOT BE DEFLATED AFTERWARD. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS 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. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." A DEFINITIVE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ACTIONS ARE REQUIRED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. 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

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    NAME AND ADDRESS: (B)(6). OCCUPATION: (B)(6). PMA/510K #: K181770. 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

    AS REPORTED, DURING A HYSTEROSALPINGOGRAM(HSG) PROCEDURE USING A INTRAUTERINE ACCESS BALLOON CATHETER, CONTRAST MEDIUM WAS LEAKING FROM THE FLO-CHECK VALVE. AFTER THE PROCEDURE, THE 2ML INFLATED BALLOON COULD NOT BE DEFLATED. THE USER USED THE CATHETER STYLET TO DEPRESS THE INFLATION PORT VALVE. THE SALINE THEN STARTED FLOWING OUT AND THE BALLOON DEFLATED. THE CATHETER WAS THEN REMOVED FROM THE PATIENT. NO DEVICE REMAIN INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447803 INTRAUTERINE ACCESS BALLOON CATHETER LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF COOK INC G30397 10086518 00827002303973

    Patients

    Seq Age Sex Outcome Treatment
    1 3CC LUER-SLIP TERUMO SYRINGE