BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING

    MDR report key: 19420651 · Received May 29, 2024

    Report

    Report Number
    9610711-2024-00135
    Event Type
    Death
    Date Received
    May 29, 2024
    Date of Event
    March 28, 2024
    Report Date
    July 29, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND FOUND NONE REGARDING THE LOT NUMBER 9520276 WITH THE SAME DEFECT. B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION, LOT NUMBER IS AVAILABLE BUT NOT THE SAMPLE. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE FOUND NONE REGARDING THE LOT NUMBER 9520276 WITH THE SAME DEFECT. THE PRODUCT REFERENCE XB63181002 LOT NUMBER 9520276 WAS MANUFACTURED IN DECEMBER 2023 FOR (B)(4). THE EXPIRY DATE IS DECEMBER 2028. THE PRODUCT REFERENCE XB63181002 LOT NUMBER 9520276 WAS MADE WITH INTERMEDIATE. REFERENCE XB631880 LOT NUMBER 9270490 MADE WITH COMPONENTS: BALLOON: ITEM NUMBER YS385070 LOT NUMBER 9215160 (BALLOON MANUFACTURED ON JULY 2023). VALVE: ITEM NUMBER ST2013 LOT NUMBER 2302200190. THIS PRODUCT WAS MADE BY OUR SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS DEFECT. THEIR INVESTIGATION CONCLUDED ON A POSSIBLE RAW MATERIAL ISSUE ON BALLOONS. A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME ITEM NUMBER XB63XX, SAME DEFECT UNINTENDED DEFLATION OVER LAST FOUR YEAR: 4 SIMILAR CASES WERE FOUND (B)(4). ACCORDING TO THE INFORMATIONS KNOWN QUALITY DATABASE WAS CHECKED AND REVEALED ONE CORRECTIVE AND PREVENTIVE ACTION: MONITORING CAPA-000152: "BALLOON ISSUES ON FOLYSIL AND SILICONE PROSTATIC CATHETERS". THE DEFLATION ISSUE ON PROSTATIC CATHETERS IS SPECICALLY MONITORED. A RMF EVALUATION WAS PERFORMED BASED ON CRIQ250 RISKS IDENTIFIED 11502 (HAZARDOUS SITUATION: CATHETER BALLOON CANNOT STAY INFLATED OR BURST).THE EVALUATION HAS SHOWED THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART. BASED ON THIS, WE CAN CONCLUDE THAT RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. A CLINICAL EVALUATION WAS PERFORMED AND CONCLUDED: "PROSTATIC CATHETERS ARE WIDELY USED IN THE FIELD OF UROLOGY FOLLOWING BLADDER OR PROSTATE SURGERIES TO PREVENT OR EVACUATE BLOOD CLOTS AND RESTORE URINARY DRAINAGE. THESE MEDICAL DEVICES MUST ONLY BE USED BY QUALIFIED AND EXPERIENCED PROFESSIONALS. THE INCIDENT OF BALLOON DEFLATION IN SILICONE PROSTATIC CATHETERS IS A KNOWN ISSUE THAT HAS BEEN DESCRIBED SOMETIMES AND IS THEN FOLLOWED-UP THROUGH A MONITORING CAPA BY COLOPLAST. IN THE ABSENCE OF THE INCRIMINATED MEDICAL DEVICES OR PHOTO, A TECHNICAL INVESTIGATION WAS NOT DONE, THEREFORE, WE CANNOT FORMALLY CONCLUDE ON THE ROOT CAUSE OF THE INCIDENT, MOREOVER AS THE INCIDENT HAPPENED TWICE IN A ROW WHILE NO OTHER COMPLAINT WAS REPORTED TO COLOPLAST ON OTHER USED CATHETERS OF THE SAME BATCH. HOWEVER, CONSIDERING THAT THE EVENT DESCRIBED AS ¿SPONTANEOUS SILICONE BALLOON DEFLATION DURING USE¿ IS A KNOWN ISSUE, AND ON THE OTHER HAND THAT A LEAKAGE OF THE VALVE WAS EVIDENCED IN THE CURRENT SITUATION), THE CAUSE OF THE BALLOON DEFLATION IS POSSIBLY A DEVICE DEFECT (VALVE LEAKAGE). THE INCIDENT OF BALLOON DEFLATION (OCCURRING TWICE) IS RATED SEVERITY LEVEL 3 IN OUR RISK LEVEL CLASSIFICATION REFERRING TO OUR RISK MANAGEMENT PROCEDURE (B)(4). WHILE THE PATIENT WAS POSSIBLY ALREADY PRESENTING WITH A UTI AT THE TIME OF THE FIRST CATHETER CHANGE, IT CANNOT BE EXCLUDED THAT THE CHANGES OF THE DEVICE MIGHT HAVE PARTICIPATED IN THE UTI. THE UTI MIGHT BE PARTIALLY RELATED TO THE DEVICE (BALLOON DEFLATION WITH RE-CATHETERIZATION), AS THE CATHETERIZATION ITSELF, THE REMOVAL OF THE CATHETER BY THE PATIENT AND THE PRIOR LAPAROSCOPIC PROSTATECTOMY ARE OTHER RISKS FACTORS FOR URINARY TRACT INFECTION. IN ADDITION, PATIENT-RELATED FACTORS (PRECARIOUS GENERAL CONDITION AND SEVERE ALCOHOLISM) GREATLY CONTRIBUTED TO THE ONSET AND DEVASTATING EVOLUTION OF THE INFECTION. THE SEPTIC SHOCK IN THE FOLLOWING DAYS IS A POST-OPERATIVE COMPLICATION THAT COULD OCCUR FOR DIFFERENT REASONS IN THIS CASE: A COMPLICATION OF THE SURGERY ITSELF, A CATHETER-RELATED INFECTION, A NOSOCOMIAL INFECTION WITH A GERM RESISTANT TO ANTIBIOTICS, THE PATIENT¿S CONDITION (PRECARIOUS GENERAL CONDITION AND SEVERE ALCOHOLISM). OVERALL, THE SEPTIC SHOCK CAN BE ATTRIBUTED TO A COMBINATION OF MANY FACTORS. WE CONSIDER THAT THE SEPTIC SHOCK AND THE DEATH OF PATIENT ARE UNLIKELY RELATED TO THE DEVICE, BUT GREATLY RELATED TO THE PATIENT¿S CONDITION (IMPAIRED GENERAL CONDITION, SEVERE ALCOHOLISM DEPRESSING THE IMMUNITY SYSTEM). MORE GENERALLY, WE ESTIMATE THAT THE INCIDENT OF BALLOON DEFLATION DURING AFTER RADICAL PROSTATECTOMY REPRESENTS A CLINICAL RISK RELATED TO RISK OF DISCOMFORT, URINE LEAKAGE, PAIN, PROSTATE FOSSA HEMORRHAGE, URINARY RETENTION, URINARY TRACT INFECTION, REINTERVENTION FOR CHANGE OF DEVICE, DIFFICULT RE-CATHETERIZATION, RATED SEVERITY LEVEL 3 REFERRING TO OUR RISK MANAGEMENT PROCEDURE (B)(4)."

    Description of Event or Problem · 0

    THIS PATIENT HAD UNDERGONE LAPAROSCOPIC RADICAL PROSTATE SURGERY. HE HAD COGNITIVE PROBLEMS AND HE HAD ALREADY TORN OUT A CATHETER. A NEW BALLOON WAS INSERTED AND INFLATED TO 30CC. 48 HOURS LATER, THE NURSE WHO NOTICED A LEAK IN THE PATIENT'S PENIS, DEFLATED THE BALLOON TO REINFLATE IT AT THE DOCTOR'S REQUEST. SHE NOTICES THAT THE VOLUME ASPIRATED FROM THE BALLOON IS NOT THAT PREVIOUSLY TRACED. WHILE INJECTING THE SERUM, SHE SEES BREACHES IN THE VALVE OF THE INFLATION ZONE ALLOWING A FEW DROPS OF NA CL TO ESCAPE. TO AVOID RE-CATHETERIZATION, THE AREA WAS WRAPPED IN A TRANSPARENT AND WATERPROOF STERILE FILM. 72 HOURS LATER, THE PATIENT SUFFERED SEPTIC SHOCK, HE WAS INTUBATED AND VENTILATED TO THE HOSPITAL. THE PATIENT HAD NOT BEEN TREATED WITH ANTIBIOTICS PRIOR TO THIS INCIDENT. PATIENT DIED OF SEPTIC SHOCK AT (B)(6) HOSPITAL.

    Description of Event or Problem · 0

    THIS PATIENT HAD UNDERGONE LAPAROSCOPIC RADICAL PROSTATE SURGERY. HE HAD COGNITIVE PROBLEMS AND HE HAD ALREADY TORN OUT A CATHETER. A NEW BALLOON WAS INSERTED AND INFLATED TO 30CC. 48 HOURS LATER, THE NURSE WHO NOTICED A LEAK IN THE PATIENT'S PENIS, DEFLATED THE BALLOON TO REINFLATE IT AT THE DOCTOR'S REQUEST. SHE NOTICES THAT THE VOLUME ASPIRATED FROM THE BALLOON IS NOT THAT PREVIOUSLY TRACED. WHILE INJECTING THE SERUM, SHE SEES BREACHES IN THE VALVE OF THE INFLATION ZONE ALLOWING A FEW DROPS OF NA CL TO ESCAPE. TO AVOID RE-CATHETERIZATION, THE AREA WAS WRAPPED IN A TRANSPARENT AND WATERPROOF STERILE FILM. 72 HOURS LATER, THE PATIENT SUFFERED SEPTIC SHOCK, HE WAS INTUBATED AND VENTILATED TO THE HOSPITAL. THE PATIENT HAD NOT BEEN TREATED WITH ANTIBIOTICS PRIOR TO THIS INCIDENT. PATIENT DIED OF SEPTIC SHOCK AT (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825366 HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9520276_XB63181002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death