BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    MDR report key: 6716809 · Received July 17, 2017

    Report

    Report Number
    1820334-2017-01597
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    June 13, 2017
    Report Date
    September 29, 2017
    Manufacturer
    COOK INC
    Product Code
    HES
    UDI-DI
    00827002171473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: TWO COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETERS WERE RETURNED FOR EVALUATION. ALSO RETURNED WAS ONE UNKNOWN DEVICE WITH LOT NUMBER 130791 AND REFERENCE NUMBER (B)(4) IN A SEALED PACKAGE. A FUNCTIONAL TEST WAS PERFORMED ON THE TWO COOK DEVICES. BOTH DEVICES INFLATED PROPERLY. WHEN DEFLATING THE BALLOONS ONE BALLOON DEFLATED FINE WITH NO ISSUES. THE PLUNGER ON THIS BALLOON MEASURED 2 MM PAST THE CONNECTOR. THE OTHER BALLOON TOOK MORE PRESSURE TO DEFLATE THE BALLOON. THE PLUNGER ON THIS BALLOON MEASURED 3 MM PAST THE CONNECTOR. A DEFINITIVE ROOT CAUSE FOR THE DEFLATION ISSUE WAS NOT ABLE TO BE DETERMINED AT. THIS TIME. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE NOTED. A REVIEW OF COMPLAINT HISTORY FOR THIS PRODUCT/LOT NUMBER COMBINATION REVEALED THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH LOT NUMBER 7692821. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING HYSTEROSALPINGOGRAPHY PROCEDURE, THE PHYSICIAN USED A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON INFLATED COMPLETELY, HOWEVER IT FAILED TO DEFLATE. THE PHYSICIAN COMPLETED THE INTENDED PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED 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
    498107 COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES) HES COOK INC N/A 00827002171473

    Patients

    Seq Age Sex Outcome Treatment
    1