BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    MDR report key: 11692525 · Received April 20, 2021

    Report

    Report Number
    1820334-2021-01166
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    November 26, 2019
    Report Date
    April 20, 2021
    Manufacturer
    COOK INC
    Product Code
    LKF
    UDI-DI
    00827002171473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER NAME AND ADDRESS- PHONE: (B)(6). OCCUPATION- HEAD OF REGULATORY AFFAIRS. PMA/510(K) #- K180291 EVENT SUMMARY: AS REPORTED, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WOULD NOT INFLATE WHEN TESTED PRIOR TO USE IN A SONOHYSTEROGRAPHY. THE BALLOON WAS ATTEMPTED TO BE INFLATED WITH WATER WITH THE PROVIDED SYRINGE. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. 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 AND A VISUAL INSPECTION 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 CATHETER LENGTH MEASURES 31CM AND WAS BENT APPROXIMATELY 15CM FROM THE DISTAL TIP. THE BALLOON WAS RUPTURED, PREVENTING INFLATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED. ONE ADDITIONAL COMPLAINT WAS RECEIVED FOR THIS PRODUCT LOT DESCRIBING THE SAME FAILURE MODE. DUE TO THE INDIVIDUAL NATURE OF THE MANUFACTURING AND INSPECTION PROCESS FOR THE DEVICES IN THE LOTS, IT IS UNLIKELY THAT THESE EVENTS ARE AN INDICATION OF DEVICE ISSUE WITHIN THE ENTIRE LOT. 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, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WOULD NOT INFLATE WHEN TESTED PRIOR TO USE IN A SONOHYSTEROGRAPHY. THE BALLOON WAS ATTEMPTED TO BE INFLATED WITH WATER WITH THE PROVIDED SYRINGE. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591789 COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF COOK INC G17147 9607640 00827002171473

    Patients

    Seq Age Sex Outcome Treatment
    1