BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    MDR report key: 8883390 · Received August 12, 2019

    Report

    Report Number
    1820334-2019-01981
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Report Date
    August 29, 2019
    Manufacturer
    COOK INC
    Product Code
    HES
    UDI-DI
    00827002178700
    PMA / PMN Number
    K891290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: REVIEWS OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS 3 OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. 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 AN ISSUE WITH THE ENTIRE LOT. THE INSTRUCTIONS FOR USE(IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE FOR INVESTIGATION. AT THE TIME OF THE COMPLAINT INVESTIGATION, ALL PRODUCTS IN THIS LOT HAVE BEEN DISTRIBUTED TO CUSTOMERS, SO NO REPRESENTATIVE PRODUCT WAS AVAILABLE FROM THE LOT FOR EVALUATION. THE COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. THE CAUSE OF THE ISSUE IS UNKNOWN. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A HYSTEROSALPINGOGRAPHY WAS COMPLETED, THE HEALTH CARE PROVIDER ATTEMPTED TO REMOVE THE COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER THAT WAS USED DURING THE PROCEDURE. THERE WERE ISSUES REMOVING THE CATHETER FROM THE UTERUS DUE TO THE BALLOON NOT DEFLATING. THEY WERE EVENTUALLY ABLE TO DEFLATE THE BALLOON. NO ADVERSE EVENT WAS REPORTED DUE TO THIS MALFUNCTION. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679003 COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES) HES COOK INC G17870 9432727 00827002178700

    Patients

    Seq Age Sex Outcome Treatment
    1