BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    MDR report key: 11712278 · Received April 22, 2021

    Report

    Report Number
    1820334-2021-01199
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    July 5, 2019
    Report Date
    April 22, 2021
    Manufacturer
    COOK INC
    Product Code
    LKF
    UDI-DI
    00827002174726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER NAME AND ADDRESS- PHONE: (B)(6). PMA/510(K) #- K180291. EVENT SUMMARY: AS REPORTED, DURING A HYSTEROSALPINGOGRAPHY, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER RUPTURED. THE BALLOON WAS INJECTED WITH 0.5ML SALINE USING THE SYRINGE INCLUDED WITH THE DEVICE, BUT THE DEVICE COULD NOT BE CLEARLY SEEN UNDER SONOGRAPHY. ANOTHER 0.5ML WAS INJECTED AND THE BALLOON COULD STILL NOT BE SEEN. NO SALINE WAS UNABLE TO BE EXTRACTED FROM THE DEVICE, SO THE USER REMOVED THE DEVICE AND DISCOVERED THE BALLOON WAS BROKEN. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE OPEN PACKAGE CONTAINING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WAS RETURNED FOR INVESTIGATION. VISUAL EXAMINATION CONFIRMED THE BALLOON CATHETER WAS RECEIVED IN A USED CONDITION. THE CATHETER WAS BOWED STARTING AT THE MANIFOLD EXTENDING TO THE DISTAL TIP. MAGNIFICATION OF THE DISTAL END OF THE CATHETER CONFIRMED THE BALLOON BURST. NO OTHER DAMAGE WAS OBSERVED ON THE DEVICE. 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 THE MOST PROBABLE CAUSE OF THE BALLOON RUPTURE WAS THE OVERINFLATION OF THE BALLOON. 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 HYSTEROSALPINGOGRAPHY, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER RUPTURED. THE BALLOON WAS INJECTED WITH 0.5ML SALINE USING THE SYRINGE INCLUDED WITH THE DEVICE, BUT THE DEVICE COULD NOT BE CLEARLY SEEN UNDER SONOGRAPHY. ANOTHER 0.5ML WAS INJECTED AND THE BALLOON COULD STILL NOT BE SEEN. NO SALINE WAS UNABLE TO BE EXTRACTED FROM THE DEVICE, SO THE USER REMOVED THE DEVICE AND DISCOVERED THE BALLOON WAS BROKEN. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608165 COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF COOK INC G17472 NS9127427 00827002174726

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR