BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    MDR report key: 11692428 · Received April 20, 2021

    Report

    Report Number
    1820334-2021-01165
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    December 2, 2019
    Report Date
    April 20, 2021
    Manufacturer
    COOK INC
    Product Code
    LKF
    UDI-DI
    00827002174719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #- K180291. EVENT SUMMARY: AS REPORTED, DURING A HYSTEROSALPINGOGRAM IN THE UTERINE CAVITY, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LEAKED AFTER INFLATION WITH 1.5ML SALINE. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE OPEN PACKAGE CONTAINING A COOK SILICONE BALLOON CATHETER WAS RETURNED FOR INVESTIGATION IN A USED CONDITION. THE DEVICE WAS BOWED. MAGNIFICATION OF THE CATHETER TIP CONFIRMED THE BALLOON WAS RUPTURED, EXPOSING THE NOTCH PORT IN THE INFLATION LINE. 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. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. 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 DEVICE IS INCLUDED WITH INSTRUCTIONS FOR USE WHICH CAUTION, ¿DO NOT OVER INFLATE. USING EXCESSIVE PRESSURE TO INFLATE THE BALLOON ON THIS DEVICE CAN CAUSE THE BALLOON TO RUPTURE. REFER TO PRODUCT LABEL OR THE INFLATION CHECK VALVE ON THE BALLOON DEVICE FOR APPROPRIATE BALLOON VOLUME.¿ BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT UNINTENDED USER ERROR CONTRIBUTED TO THIS INCIDENT. 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.

    Description of Event or Problem · 1

    AS REPORTED, DURING A HYSTEROSALPINGOGRAM IN THE UTERINE CAVITY, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LEAKED AFTER INFLATION WITH 1.5ML SALINE. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591399 COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF COOK INC G17471 9991452 00827002174719

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR