BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY NEEDLE KIT, PASSIVE

    MDR report key: 4890073 · Received July 3, 2015

    Report

    Report Number
    1723170-2015-00767
    Event Type
    Malfunction
    Date Received
    July 3, 2015
    Date of Event
    May 8, 2015
    Report Date
    February 23, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Removal / Correction Number
    Z-2324/2325-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE SECOND BIOPSY NEEDLE REQUESTED. REPLACEMENT DEVICE SHIPPED TO SITE. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS AS THE SITE DISCARDED THE DISPOSABLE DEVICE. ON 06/03/2015, A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE PATIENT WAS NOT COMPROMISED BY THE MEDTRONIC NAVIGATION SYSTEM, BUT THE HOSPITAL REFUSED TO RETURN THE BIOPSY NEEDLE. ON 06/08 2015, ISSUE RESOLVED WITH PART REPLACEMENT. NO FURTHER ISSUES HAVE BEEN REPORTED. ALTHOUGH THIS DEVICE WAS NOT RETURNED FOR ANALYSIS, AN INVESTIGATION IS CURRENTLY IN-PROCESS RELATED TO SIMILAR REPORTED EVENTS. UPON COMPLETION OF THE INVESTIGATION, ANY NEW INFORMATION WILL BE COMMUNICATED VIA SUPPLEMENTAL MDR SUBMISSION(S).

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS DISCOVERED ON 27-JAN-2016, THAT AN INCORRECT DATE WAS REFERENCED IN A PREVIOUS SUPPLEMENTAL 3500A SUBMISSION. THE REPORTED DATE OF 16-AUG-2016 WAS REPORTED INCORRECTLY AND SHOULD BE 16-AUG-2015. STATEMENT IN PREVIOUS SUPPLEMENTAL 3500A SUBMISSION SHOULD READ: ¿ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2015. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2015. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.¿

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE PASSIVE BIOPSY NEEDLE (PBN), MNAV PART NUMBER (B)(4), LOT NUMBER 066503515, FOUND ADDITIONAL COMPLAINTS REGARDING THIS ISSUE, REPORTED IN MDRS 1723170-2015-00760, 1723170-2015-00761, 1723170-2015-00762, 1723170-2015-00763, 1723170-2015-00764, 1723170-2015-00765, 1723170-2015-00766 AND 1723170-2015-00767. NONE OF THESE REPORTED EVENTS RESULTED IN PATIENT HARM. FURTHER INVESTIGATION INTO THIS ISSUE WAS COMPLETED BY A CROSS-FUNCTIONAL TEAM, INCLUDING HARDWARE QUALITY ENGINEERING, SUPPLIER QUALITY ENGINEERING, MANUFACTURING ENGINEERING AND THE SUPPLIER. THE INVESTIGATION DETERMINED THAT THE SUPPLIER PROVIDED PRODUCT TO MEDTRONIC NAVIGATION, INC. (MNAV) WHERE THE SPHERE/SPACER ASSEMBLY ON THE PASSIVE BIOPSY NEEDLE MOVES ALONG THE SHAFT OF THE NEEDLE WHEN IT IS INTENDED TO BE AFFIXED TO THE SHAFT WITHOUT MOVEMENT. THE DEFECT WAS NOT IDENTIFIED THROUGH THE MANUFACTURING PROCESS OR INSPECTION AT THE SUPPLIER. THE PART IS SUPPLIED STERILE AND IS NOT REMOVED FROM STERILE PACKAGING AT MNAV FOR INSPECTION. THE MALFUNCTION WHERE THE SPHERE/SPACER ASSEMBLY MOVES ALONG THE SHAFT OF THE NEEDLE IS SUCH THAT THE DEFECT MAY NOT BE DETECTABLE DURING SET-UP, OR USE. THE TECHNICAL ROOT CAUSE OF THE MANUFACTURING ISSUE WAS DETERMINED TO BE AN INADEQUATE AMOUNT OF ADHESIVE APPLIED TO THE BOND JOINTS OF THE SPHERE SPACER ASSEMBLY AND THE NEEDLE CANNULA. THE INADEQUACY WAS FOUND TO BE DUE TO VARIATIONS IN THE ADHESIVE DISPENSING PROCESS. THIS ISSUE WAS DOCUMENTED IN THE MNAV HARDWARE DEFECT TRACKING DATABASE. THE PRIMARY PROCESS ROOT CAUSE IS AN INSUFFICIENT PROCESS CHARACTERIZATION PROCEDURE THAT DID NOT CONSIDER PRODUCTION LOT SIZE, WITH A CONTRIBUTING PROCESS ROOT CAUSE OF INSUFFICIENT PROCESS QUALIFICATION SAMPLING REQUIREMENTS TO SAMPLE FROM A LOT THAT REPRESENTS A TYPICAL PRODUCTION LOT SIZE. PRODUCTION OF THE PART WAS HALTED UNTIL THE ISSUE WAS RESOLVED. ON 07/17/2015, A VOLUNTARY CORRECTIVE ACTION NOTIFICATION WAS PROVIDED TO THE AFFECTED SITES TO REPLACE AND REMOVE THE AFFECTED BIOPSY NEEDLE KITS. THE SCOPE OF THIS FIELD ACTION IS LIMITED DISTRIBUTION BETWEEN (B)(4) 2015 WITH THE FOLLOWING PART AND CORRESPONDING LOT NUMBERS: PASSIVE BIOPSY NEEDLE KIT P/N (B)(4), LOT NUMBERS: 066503515, 066504315 AND 066506515 AND FPU PASSIVE BIOPSY NEEDLE KIT P/N (B)(4), LOT NUMBERS: 0007525461 AND 0007599312. THE FIELD ACTION INCLUDES A REVIEW OF CUSTOMER INVENTORY, QUARANTINE AND RETURN OF ANY AFFECTED UNITS STILL IN THE FIELD. THE INVESTIGATION CONCLUDED THE NEED FOR CORRECTIVE ACTION, WHICH WILL BE PLANNED, IMPLEMENTED, AND TRACKED WITHIN MEDTRONIC NAVIGATION¿S CAPA SYSTEM UNDER CAPA (B)(4).

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL BIOPSY PROCEDURE, THE SURGEON ALLEGED A DEFECTIVE BIOPSY NEEDLE. IT WAS STATED THAT AT FIRST THE SITE WAS TRACKING THE NEEDLE JUST FINE, AND WAS ABLE TO GET DOWN TO TARGET AND GATHER SAMPLES. THE SPHERES UNEXPECTEDLY SLID DOWN THE BIOPSY NEEDLE TO THE STOPPER. THE SURGEON WAS NOT PUTTING ANY PRESSURE ON THE NEEDLE WHEN THIS OCCURRED. IN TROUBLE-SHOOTING, THE MEDTRONIC REPRESENTATIVE PROVIDED A SECOND BIOPSY NEEDLE TO CONTINUE THE PROCEDURE, HOWEVER, THE ISSUE WAS THE SAME. THEY WENT STRAIGHT TO TARGET WHEN THE SPHERES SLID DOWN THE SHAFT ALL THE WAY DOWN TO THE STOPPER. THIS DID NOT COMPROMISE THE SURGERY AS THE SURGEON HAD ALREADY NAVIGATED TO TARGET AND COLLECTED SOME SAMPLES. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433908 BIOPSY NEEDLE KIT, PASSIVE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NONE 066503515

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR