BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN-END URETERAL CATHETER

    MDR report key: 7248317 · Received February 7, 2018

    Report

    Report Number
    1820334-2018-00104
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 12, 2018
    Report Date
    April 9, 2018
    Manufacturer
    COOK INC
    Product Code
    DQO
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION EVALUATION: THE INVESTIGATION INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. ONE PACKAGE LABELED RPN 020015 AND LABEL LOT NUMBER 8242725 WAS RECEIVED. THE CATHETER WAS RECEIVED IN USED CONDITION AND SEPARATED INTO THREE SEGMENTS. THE CATHETER WAS RETURNED WITHOUT THE 050010 ADAPTER. THE DISTAL SEGMENT MEASURED 2.6 CM FROM DISTAL TIP TO POINT OF SEPARATION. THE SHORT SEGMENT MEASURED 7 MM AND THE LONG SEGMENT MEASURED 65.7CM FROM THE PROXIMAL END TO THE POINT OF SEPARATION. THE TOTAL LENGTH OF SEPARATED SEGMENTS MEASURED 69 CM WITH THE FIRST FIVE INK BANDS INTACT, THIS INDICATES NO MISSING PIECES. THE LENGTH IS WITHIN SPECIFIED TOLERANCE OF 65CM-73CM. THE POINT OF SEPARATION ON THE 2.6M SEGMENT AND THE DISTAL END OF THE 7MM SEGMENT WERE MATING FRACTURES WITH A SLIGHTLY PINCHED APPEARANCE; PINCHED APPEARANCE LIKELY CAUSED BY THE GRASPER USED TO REMOVE THE SEGMENT FROM THE BLADDER. THE POINT OF SEPARATION BETWEEN THE PROXIMAL END OF THE 7MM SEGMENT AND THE DISTAL END OF THE 65.7CM SEGMENT WAS SEPARATED IN A DIAGONAL DIRECTION AND IS A MATING FRACTURE. NO EVIDENCE OF ANY MANUFACTURING ANOMALIES OBSERVED WITH THE CATHETER MATERIAL. THE CATHETER MATERIAL WAS PLIABLE AND DID NOT SEPARATE WHEN ACUTELY BENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES RELATED TO THE COMPLAINT ISSUE NOTED FOR THIS DEVICE LOT NUMBER 8242725. A REVIEW OF COMPLAINT HISTORY REVEALED THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8242725. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. 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. BASED ON THE INFORMATION AVAILABLE A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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. INVESTIGATION EVALUATION: THE INVESTIGATION INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. ONE PACKAGE LABELED RPN 020015 AND LABEL LOT NUMBER 8242725 WAS RECEIVED. THE CATHETER WAS RECEIVED IN USED CONDITION AND SEPARATED INTO THREE SEGMENTS. THE CATHETER WAS RETURNED WITHOUT THE 050010 ADAPTER. THE DISTAL SEGMENT MEASURED 2.6 CM FROM DISTAL TIP TO POINT OF SEPARATION. THE SHORT SEGMENT MEASURED 7 MM AND THE LONG SEGMENT MEASURED 65.7CM FROM THE PROXIMAL END TO THE POINT OF SEPARATION. THE TOTAL LENGTH OF SEPARATED SEGMENTS MEASURED 69 CM WITH THE FIRST FIVE INK BANDS INTACT, THIS INDICATES NO MISSING PIECES. THE LENGTH IS WITHIN SPECIFIED TOLERANCE OF 65CM-73CM. THE POINT OF SEPARATION ON THE 2.6M SEGMENT AND THE DISTAL END OF THE 7MM SEGMENT WERE MATING FRACTURES WITH A SLIGHTLY PINCHED APPEARANCE; PINCHED APPEARANCE LIKELY CAUSED BY THE GRASPER USED TO REMOVE THE SEGMENT FROM THE BLADDER. THE POINT OF SEPARATION BETWEEN THE PROXIMAL END OF THE 7MM SEGMENT AND THE DISTAL END OF THE 65.7CM SEGMENT WAS SEPARATED IN A DIAGONAL DIRECTION AND IS A MATING FRACTURE. NO EVIDENCE OF ANY MANUFACTURING ANOMALIES OBSERVED WITH THE CATHETER MATERIAL. THE CATHETER MATERIAL WAS PLIABLE AND DID NOT SEPARATE WHEN ACUTELY BENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES RELATED TO THE COMPLAINT ISSUE NOTED FOR THIS DEVICE LOT NUMBER 8242725. A REVIEW OF COMPLAINT HISTORY REVEALED THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8242725. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. 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. BASED ON THE INFORMATION AVAILABLE A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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 · 1

    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 DURING AN INSERTION OF URETERIC STENT PROCEDURE THE END OF THE OPEN-END URETERAL CATHETER BROKE INTO 2 SMALLER PIECES INSIDE THE PATIENT¿S BLADDER. THE SURGEON USED A STENT GRASPER TO REMOVE THE SMALL PIECES FROM THE BLADDER. NO PORTION OF THE DEVICE REMAINED IN THE PATIENT¿S BODY. AS REPORTED, THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93760 OPEN-END URETERAL CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention