BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIBA BIOPSY NEEDLE

    MDR report key: 12455380 · Received September 10, 2021

    Report

    Report Number
    1820334-2021-02137
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 15, 2022
    Manufacturer
    COOK INC
    Product Code
    MJG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B1. ADDITIONAL INFORMATION: B5. 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. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. IT WAS REPORTED BY CARLA PIZARRO OF ATILIO PALMIERI S.R.L. THAT ON 14JUL2021 A CHIBA BIOPSY NEEDLE (RPN: DCHN-18-20.0; LOT: 10196030) TORE A COMPETITOR¿S WIRE GUIDE (MANUFACTURER, RPN, AND LOT UNKNOWN). DURING A KIDNEY STONE PROCEDURE, THE PATIENT WAS POSITIONED PRONE AND ACCESS TO THE KIDNEY WAS ATTEMPTED VIA PUNCTURES TO THE UPPER AND LOWER CALYX. AFTER PUNCTURING THE LOWER CALYX WITH THE CHIBA NEEDLE, URINE LEAKAGE AND CONTRAST PASSAGE WERE OBSERVED; HOWEVER, THE GUIDE WIRE (MANUFACTURER, RPN, AND LOT UNKNOWN) WAS UNABLE TO BE ADVANCED. THE USER THEN REMOVED THE GUIDE WIRE AND NOTED THAT THE HYDROPHILIC COATING WAS ¿BROKEN¿. AN ADDITIONAL CHIBA NEEDLE AND HYDROPHILIC GUIDES WERE OBTAINED BUT THE USER EXPERIENCED THE SAME FAILURE. AS A RESULT, THE PATIENT HAS SMALL PUNCTURES FROM THE CHIBA NEEDLE, OPERATION TIME WAS PROLONGED AND ¿RESIDUAL FRAGMENTS REMAINED DUE TO PROLONGED¿. IT WAS REPORTED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS EVENT. IT WAS NOTED NO FORCE WAS APPLIED. IT WAS ALSO NOTED THAT THE CUSTOMER BELIEVES THE NEEDLE SHOULD NOT HAVE TORN THE WIRE GUIDE AS THE WIRE GUIDE HAS A ¿DIAMOND TIP¿. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, AND MANUFACTURING INSTRUCTIONS (MI) 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. HOWEVER, A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT AND RELATED SUBASSEMBLY LOTS REVEALED NO RECORDED NON-CONFORMANCES. FOUR ADDITIONAL FINAL LOTS RELATED TO THE SUBASSEMBLY LOTS WERE ALSO REVIEWED AND REVEALED NO RECORDED NON-CONFORMANCES. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD THERE ARE NO INSTRUCTIONS FOR USE (IFU) ASSOCIATED WITH THE CHIBA BIOPSY NEEDLE. BASED ON THE AVAILABLE INFORMATION, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, COOK DID NOT CONFIRM THE COMPLAINT AS THE COMPLAINT DEVICE DID NOT MALFUNCTION AS IT WAS A COMPETITOR'S WIRE GUIDE THAT FAILED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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

    DURING THE INVESTIGATION, IT WAS DETERMINED THAT THERE WAS NO MALFUNCTION OF THE NEEDLE.

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: MJG. CUSTOMER PERSON: PHONE: (B)(6). OCCUPATION: REGULATORY AFFAIRS ANALYST. PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT REQUIRED A CHIBA BIOPSY NEEDLE FOR A KIDNEY STONE PROCEDURE. DURING THE PROCEDURE, THE PATIENT WAS IN PRONE POSITION. THE USER GAINED ACCESS VIA THE UPPER CALYX WITH THE INTENDED LOCATION BEING THE LOWER CALYX. THE LOWER CALYX WAS PUNCTURED AND URINE LEAKAGE WAS CONFIRMED. AT THIS POINT, CONTRAST WAS ABLE TO BE INJECTED THROUGH THE DEVICE; HOWEVER, AN UNKNOWN HYDROPHILIC "DIAMOND TIP" WIRE GUIDE WAS UNABLE TO BE ADVANCED. WHEN THE WIRE GUIDE WAS REMOVED, THE USER OBSERVED THAT "THE HYDROPHILIC PACKAGING WAS BROKEN". AN ADDITIONAL NEEDLE AND WIRE GUIDES WERE OBTAINED BUT THE USER CONTINUED TO EXPERIENCE THE REPORTED FAILURE. THE PATIENT SUSTAINED MULTIPLE PUNCTURES AND SURGERY WAS PROLONGED AS A RESULT OF THIS EVENT. ON 02SEP2021, IT WAS REPORTED THAT "RESIDUAL FRAGMENTS REMAINED [IN THE PATIENT] DUE TO PROLONGED", THUS PROMPTING THIS REPORT. IT WAS NOTED THAT PUNCTURE WITH THE NEEDLE WAS PERFORMED REPEATEDLY AND NO FORCE WAS APPLIED TO THE NEEDLE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352225 CHIBA BIOPSY NEEDLE MJG COOK INC N/A 10196030

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other HYDROPHILIC WIRE GUIDE-UNKNOWN MANUFACTURER