BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDSTEIN SONOBIOPSY CATHETER

    MDR report key: 16460869 · Received March 1, 2023

    Report

    Report Number
    1820334-2023-00200
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    November 17, 2022
    Report Date
    March 21, 2023
    Manufacturer
    COOK INC
    Product Code
    HFF
    PMA / PMN Number
    K060908
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER OCCUPATION = UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: IT WAS REPORTED THAT THE ACORN-SHAPED POSITIONER OF A GOLDSTEIN SONOBIOPSY CATHETER CAME OFF OF THE CATHETER DURING A SALINE INFUSION SONOHYSTEROGRAM (SIS) PROCEDURE AND WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED. APPROXIMATELY 30 HOURS LATER, THE PATIENT FOUND THE DEVICE PART IN THEIR VAGINAL CANAL AT HOME. THE PATIENT WAS NOT HOSPITALIZED OR HAD PROLONGED HOSPITALIZATION DUE TO THE EVENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE EVENT. 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 INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL (QC) PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. REVIEW OF THE CUSTOMER TESTIMONY AND RELEVANT MANUFACTURING DOCUMENTS DOES NOT INDICATE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATIONS AND DOES NOT SUGGEST ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE ARE NONCONFORMING. A SEARCH OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. A COMPLAINT HISTORY DATABASE SEARCH COULD NOT BE CONDUCTED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. ACCORDINGLY, NO PHYSICAL EXAMINATION COULD BE PERFORMED. BASED UPON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE FOR THE COMPLAINT WAS THE CUSTOMER'S FAILURE TO FOLLOW INSTRUCTIONS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    IT WAS REPORTED THAT THE ACORN-SHAPED POSITIONER OF A GOLDSTEIN SONOBIOPSY CATHETER CAME OFF OF THE CATHETER DURING A SALINE INFUSION SONOHYSTEROGRAM (SIS) PROCEDURE AND WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED. APPROXIMATELY 30 HOURS LATER, THE PATIENT FOUND THE DEVICE PART IN THEIR VAGINAL CANAL AT HOME. THE PATIENT WAS NOT HOSPITALIZED OR HAD PROLONGED HOSPITALIZATION DUE TO THE EVENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE EVENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921386 GOLDSTEIN SONOBIOPSY CATHETER HFF ASPIRATOR, ENDOMETRIAL HFF COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other