BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET

    MDR report key: 6749734 · Received July 28, 2017

    Report

    Report Number
    1820334-2017-01867
    Event Type
    Injury
    Date Received
    July 28, 2017
    Date of Event
    July 13, 2017
    Report Date
    December 21, 2017
    Manufacturer
    COOK INC
    Product Code
    KOB
    UDI-DI
    00827002148994
    PMA / PMN Number
    K810368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: ADVERSE EVENT AND PRODUCT PROBLEM. COMMON NAME AND PRODUCT CODE: KOB. PATIENT CODE: DEVICE FRAGMENTS IN PATIENT. REPORTABLE EVENT TYPE: SERIOUS INJURY. INVESTIGATION SUMMARY: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, SPECIFICATIONS, QUALITY CONTROL, MANUFACTURING INSTRUCTIONS AND A DRAWING OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. IT WAS REPORTED THAT DURING ONE PROCEDURE, "A PIECE OF GUIDE WIRE BROKE OFF DURING REMOVAL." ALTHOUGH THE COMPLAINT INDICATES THAT 5 PRODUCTS WERE USED, IT IS DESCRIBED AS A SINGLE WIRE. FURTHER CLARIFICATION WAS PROVIDED CONFIRMING THAT ONE PATIENT WAS INVOLVED DURING ONE PROCEDURE. IT WAS INITIALLY UNCLEAR WHETHER THE CUSTOMER MAY HAVE ATTEMPTED TO WITHDRAW THE WIRE THROUGH THE NEEDLE DURING THE PROCEDURE; HOWEVER, IT WAS DETERMINED THAT THE CUSTOMER HAD DIFFICULTY DILATING THE TRACT DUE TO THE PATIENT'S LARGE SIZE. THIS DIFFICULTY MANIPULATING THE DILATORS MAY HAVE CONTRIBUTED TO DAMAGE TO THE WIRE. ON 20OCT2017, THE REPRESENTATIVE WAS ABLE TO PROVIDE CONFIRMATION THAT THE CUSTOMER "REPORTED THAT DISTAL PART OF THE WIRE BROKE OFF DURING REMOVAL (AFTER THEY FIXED NEPHROSTOMY CATHETER). THEY TRIED TO WITHDRAW THE WIRE THROUGH THE NEEDLE AND THEN REALIZED THAT DISTAL PART WAS BROKE OFF. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE WAS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. OTHER COMPLAINTS INVOLVING THIS LOT ARE RELATED TO THIS EVENT, INVOLVING DIFFERENT COMPONENTS OF THE SAME SET(S). THE IFU INCLUDED WITH EVERY DEVICE INSTRUCTS THAT THE WIRE SHOULD REMAIN IN PLACE WHILE THE NEEDLE IS WITHDRAWN. THE WIRE SHOULD NOT BE WITHDRAWN THROUGH THE NEEDLE AS IT CAN RESULT IN DAMAGE SUCH AS SEPARATION OR UNRAVELING. THE IFU SPECIFICALLY INSTRUCTS THE USER TO MAINTAIN THE POSITION OF THE WIRE GUIDE WHILE WITHDRAWING THE NEEDLE OVER IT. RISK SPECIFICATION DOCUMENT ADDRESSES THE POTENTIAL FAILURE MODE "DIFFICULT OR UNABLE TO WITHDRAW WIRE GUIDE" LEADING TO THE POTENTIAL EFFECT OF "WIRE GUIDE BREAKAGE LEADING TO.... RETRIEVAL" CAUSED BY "DAMAGE TO WIRE GUIDE DURING USE." BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE WILL BE TRENDED AS PRODUCT USE AND HANDLING RELATED. THE QUALITY ENGINEERING RISK ASSESSMENT FOR THIS FAILURE MODE WAS REVIEWED AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. THE APPROPRIATE PERSONNEL WILL BE NOTIFIED AND WE WILL 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

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A PERCUTANEOUS PIGTAIL NEPHROSTOMY SET. THE GUIDE WIRE BROKE DURING THE PLACEMENT PROCEDURE. THE BROKEN FRAGMENT REMAINED IN THE KIDNEY. THE FRAGMENT WAS THEN RETRIEVED BY AN UNSPECIFIED METHOD DURING THE INITIAL PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURES WERE PERFORMED. NO FRAGMENT REMAINS WITHIN THE PATIENTS' BODY. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530163 PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) KOB COOK INC N/A 00827002148994

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention