BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-CORE COAXIAL BIOPSY NEEDLE SET

    MDR report key: 6747256 · Received July 27, 2017

    Report

    Report Number
    1820334-2017-02172
    Event Type
    Injury
    Date Received
    July 27, 2017
    Date of Event
    July 12, 2017
    Report Date
    January 10, 2018
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002087903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE AND EXPIRATION DATE; PMA/510(K) #:K973565. INVESTIGATION - EVALUATION: A REVIEW OF DIMENSIONAL VERIFICATION, INSPECTION OF UNUSED PRODUCT, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE, SPECIFICATIONS, VISUAL INSPECTION, AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE INVOLVED IN THIS COMPLAINT WAS DISPOSED OF AND SO WAS NOT RETURNED; HOWEVER, THE CUSTOMER DID RETURN 49 ADDITIONAL UNOPENED DEVICES. 4 OF THESE DEVICES CONTAINED BIOPSY NEEDLES FROM THE SAME SUPPLIER LOT AS THE DEVICE INVOLVED IN THIS COMPLAINT; THESE 4 DEVICES WERE EXAMINED THROUGH A DEVICE FAILURE ANALYSIS. THE 4 DEVICES WERE ALL FOUND TO BE WITHIN SPEC. A DOCUMENT-BASED INVESTIGATION EVALUATION SHOWED NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A 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. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE PROVIDED INFORMATION, INSPECTION OF RETURNED PRODUCT, AND THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME.THIS COMPLAINT IS CONSIDERED UNCONFIRMED. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A RENAL BIOPSY USING A QUICK-CORE COAXIAL BIOPSY NEEDLE SET. TWO QUICK-CORE COAXIAL BIOPSY NEEDLE SETS WERE USED IN AN ATTEMPT TO GAIN A SUCCESSFUL BIOPSY. BOTH ATTEMPTS WERE NOT SUCCESSFUL; THE CUSTOMER OBTAINED A COMPETITOR PRODUCT AND COMPLETED THE PROCEDURE. THE CUSTOMER REPORTS "THE QUICK CORE COAXIAL BIOPSY NEEDLE CAUSED A HEMATOMA IN A PATIENT DURING OR AFTER A BIOPSY IN THE KIDNEY." THE CUSTOMER ADVISED THAT AN ADDITIONAL LAB WAS NEEDED DUE TO THE HEMATOMA. NO FURTHER INFORMATION WAS PROVIDED; ADDITIONAL PATIENT AND EVENT DETAILS WERE REQUESTED. THIS IS ONE OF TWO REPORTS BEING SUBMITTED. REFERENCE MDR NUMBERS 1820334-2017-02170 AND 1820334-2017-02172 FOR THE TWO DEVICES. THE SAME PATIENT IS INVOLVED IN EACH REPORT. RATIONALE FOR 2 MEDWATCH REPORTS: MDR NUMBER 1820334-2017-02170 ADDRESSES THE HEMATOMA ON THE SECOND DEVICE AND MDR NUMBER 1820334-2017-02172 ADDRESSES THE UNCONFIRMED HEMATOMA THAT WAS REPORTED ON THE FIRST DEVICE. ADDITIONAL INFORMATION RECEIVED CLARIFIED, " THE INABILITY TO OBTAIN A SPECIMEN WITH INITIAL NEEDLE PLACEMENT REQUIRED ADDITIONAL NEEDLE ACCESS, WHICH LED TO HEMATOMA/LABWORK/ ADDITIONAL RECOVERY TIME." THEREFORE, IT IS IDENTIFIED THAT THE HEMATOMA REFERS TO THE SECOND DEVICE (1820334-2017-02170) ONLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A RENAL BIOPSY USING A QUICK-CORE COAXIAL BIOPSY NEEDLE SET. TWO QUICK-CORE COAXIAL BIOPSY NEEDLE SETS WERE USED IN AN ATTEMPT TO GAIN A SUCCESSFUL BIOPSY. BOTH ATTEMPTS WERE NOT SUCCESSFUL; THE CUSTOMER OBTAINED A COMPETITOR PRODUCT AND COMPLETED THE PROCEDURE. THE CUSTOMER REPORTS "THE QUICK CORE COAXIAL BIOPSY NEEDLE CAUSED A HEMATOMA IN A PATIENT DURING OR AFTER A BIOPSY IN THE KIDNEY." THE CUSTOMER ADVISED THAT AN ADDITIONAL LAB WAS NEEDED DUE TO THE HEMATOMA. NO FURTHER INFORMATION WAS PROVIDED; ADDITIONAL PATIENT AND EVENT DETAILS WERE REQUESTED. THIS IS ONE OF TWO REPORTS BEING SUBMITTED. REFERENCE MDR NUMBERS 1820334-2017-02170 AND 1820334-2017-02172 FOR THE TWO DEVICES. THE SAME PATIENT IS INVOLVED IN EACH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529191 QUICK-CORE COAXIAL BIOPSY NEEDLE SET KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 00827002087903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention