BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    MDR report key: 11464057 · Received March 11, 2021

    Report

    Report Number
    1820334-2021-00921
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 22, 2021
    Report Date
    May 3, 2021
    Manufacturer
    COOK INC
    Product Code
    LKF
    UDI-DI
    00827002171473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. EVENT SUMMARY AS REPORTED, DURING A HYSTEROSALPINGO-CONTRAST-SONOGRAPHY (HYCOSY) PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THE BALLOON BURST. WHILE THE PHYSICIAN WAS ATTEMPTING TO INFLATE THE BALLOON PRIOR TO INSERTION, IT BURST. HE TRIED ANOTHER CATHETER AND IT ALSO BURST AFTER INSERTION AND BROKE INSIDE OF THE UTERUS. THERE WAS NO HARM TO THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT THE BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE INVESTIGATION - EVALUATION REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND QUALITY CONTROL PROCEDURES OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. NO DEVICE WAS RETURNED FOR INVESTIGATION. ACCORDINGLY, NO PHYSICAL EXAMINATIONS WERE PERFORMED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. 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. THERE WERE NO IDENTIFIED GAPS IN THE QUALITY CONTROL PROCEDURES. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THE DEVICE IS INCLUDED WITH INSTRUCTIONS FOR USE WHICH STATE, "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING 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 TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    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.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510K #: K180291. 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 HYCOSY PROCEDURE USING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER, THE BALLOON BURST. WHILE THE PHYSICIAN WAS ATTEMPTING TO INFLATE THE BALLOON PRIOR TO INSERTION, IT BURST (REFERENCE PATIENT IDENTIFIER (B)(4)). HE TRIED ANOTHER CATHETER AND IT ALSO BURST AFTER INSERTION AND BROKE INSIDE OF THE UTERUS. THERE WAS NO HARM TO THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT THE BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358551 COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF COOK INC G17147 9915739 00827002171473

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR ULTRASOUND PROBE.