BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    MDR report key: 12920725 · Received December 2, 2021

    Report

    Report Number
    1820334-2021-02625
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 9, 2021
    Report Date
    February 9, 2022
    Manufacturer
    COOK INC
    Product Code
    LKF
    UDI-DI
    00827002178700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K #: K180291. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803. UPON FURTHER INVESTIGATION, THIS EVENT IS NOT REPORTABLE. AN MDR GUIDANCE FOR MANUFACTURERS ISSUED IN 1997 STATED THAT ONCE A MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, A PRESUMPTION THAT THE MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY HAS BEEN ESTABLISHED. THIS PRESUMPTION WILL CONTINUE UNTIL EITHER THE MALFUNCTION HAS CAUSED OR CONTRIBUTED TO NO FURTHER DEATHS OR SERIOUS INJURIES FOR TWO YEARS, OR THE MANUFACTURER CAN SHOW THROUGH VALID DATA THAT THE LIKELIHOOD OF ANOTHER DEATH OR SERIOUS INJURY AS A RESULT OF THE MALFUNCTION IS REMOTE. A DETAILED REVIEW OF COMPLAINT HISTORY USING A VALIDATED REPORT REVEALED THAT THERE HAVE BEEN NO DEATHS OR SERIOUS INJURIES PER 21 CFR PART 803.3, DUE TO A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER BURST OR LEAK DURING OR PRIOR TO THE PROCEDURE FROM 01JUN2019 THROUGH 13JAN2022. THEREFORE, COOK WILL CEASE MALFUNCTION REPORTING FOR EVENTS WHERE A (J-CHSG) SILICONE BALLOON HSG CATHETER BALLOON BURSTS OR LEAKS DURING OR PRIOR TO THE PROCEDURE. THE RECURRENCE OF A SERIOUS INJURY OR DEATH FOR THE SAME MALFUNCTION WILL TRIGGER THE RESUMPTION OF MANDATORY REPORTING, PER 21 CFR PART 803.50. AS SUCH, THIS EVENT NO LONGER MEETS THE SET CRITERIA FOR A REPORTABLE EVENT; NO FURTHER REPORTS REGARDING THIS EVENT WILL BE SUBMITTED. 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

    AS REPORTED, THE OPERATOR CHECKED THE COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER PRIOR TO USE AND DISCOVERED THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 0

    NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818676 COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF COOK INC G17870 14048852 00827002178700

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown