BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLARIS® SPV KIT PREATTACHED / BO19-10

    MDR report key: 19815090 · Received July 24, 2024

    Report

    Report Number
    3001587388-2024-24249
    Event Type
    Death
    Date Received
    July 24, 2024
    Date of Event
    July 12, 2024
    Report Date
    July 31, 2024
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K141227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY DEPARTMENT CONDUCTED VARIOUS ANALYSES ON THE RETURNED DEVICE: VISUAL INSPECTION : VALVE WAS RETURNED IN P03 POSITION WITH A PART OF CATHETER CONNECTED TO THE OUTPUT CONNECTOR. PRESSURE TESTING BEFORE DECONTAMINATION : SLIGHT INSTABILITY IN RETURN PRESSURE 3 CAUSED BY THE PRESENCE OF A LARGE PIECE OF PHYSIOLOGICAL DEBRIS IN THE SEAT OF THE BALL-CONE SYSTEM INSIDE THE CONNECTOR PROGRAMMING CONTROL BEFORE DECONTAMINATION: THE RESULT IS COMPLIED WITHIN OUR SPECIFICATION, THE PHYSIOLOGICAL DEBRIS IS NOW OUT OF THE CONNECTOR. THE BATCH FILE HAS BEEN REVIEWED AND THE VALVE COMPLIES WITH THE EXPECTED SPECIFICATIONS WHEN RELEASE FROM PRODUCTION. ACCORDING TO COMPLEMENTARY INFORMATION PROVIDED BY THE HOSPITAL CENTER, THE PATIENT UNDERWENT A SURGICAL OPERATION UNDER COMPLICATED HEALTH CONDITIONS (MULTIPLE OPERATIONS, CANCER, COMPLEX DIGESTIVE TRACT). HOSPITALIZATION IN JULY WAS FOR THE RETURN OF HYDROCEPHALUS SYMPTOMS ASSOCIATED WITH A SEMI-COMATOSE STATE (CONFIRMED BY MRI IMAGING, BUT NO IMPROVEMENT DESPITE LUMBAR PUNCTURE OF CSF). THERE WAS A SUSPICION OF HYPODRAINAGE DUE TO POOR POSITIONING OF THE DISTAL CATHETER. IN FACT, IMAGING SHOWED THAT THE PERITONEAL WALL WAS NOT BREACHED DURING THE INITIAL INSERTION. DURING REVISION SURGERY, THE DISTAL CATHETER WAS EXTERNALIZED BY REPOSITIONING THE ABDOMINAL SCAR, AND THE CORRECT FUNCTIONING OF THE SHUNT WAS CONFIRMED (FLOW OF CSF IN THE SHUNT). THE SAME CATHETER WAS REPOSITIONED IN THE PERITONEAL SPACE. UNFORTUNATELY, THIS TIME THE CATHETER WAS INADVERTENTLY PLACED IN A LOOP OF THE SMALL INTESTINE. THIS PERFORATION LED TO DIGESTIVE COMPLICATIONS AND THE INTERVENTION OF A VISCERAL SURGEON. THE HYDROCEPHALUS WAS NOT RESOLVED, AND THE PHYSICIAN CHOSE TO EXTERNALIZE THE DISTAL PART OF THE SHUNT IN ORDER TO CONNECT IT TO AN EXTERNAL SHUNT BAG. FINALLY A HYPERDRAINAGE HAS BEEN DETECTED. IN CONCLUSION OF THESE TESTS PERFORMED BY THE QUALITY DEPARTMENT, A PRESENCE OF PHYSIOLOGICAL RESIDUES HAS BEEN DETECTED. THE INSTABILITY AT POSITION 3 CAUSED BY THE PRESENCE OF PHYSIOLOGICAL RESIDUES CANNOT BE THE CAUSE OF MASSIVE DRAINAGE. SOPHYSA'S NOTICE CONTRAINDICATES THE USE OF EXTERNAL DRAINAGE WITH A VALVE, INDEED THE TWO SYSTEMS COULD INTERFERE WITH EACH OTHER AND DISRUPT CONTROL OF THE DRAINAGE.

    Additional Manufacturer Narrative · 0

    AWAITING FURTHER INFORMATION AND PRODUCT RETURN.

    Description of Event or Problem · 0

    IMPLANTATION OF A POLARIS KIT REF SPV-2010 HAS BEEN PERFORMED BY DR (B)(6) ON (B)(6) 2024. THE PATIENT WAS HOSPITALISED FROM (B)(6) 2024 WITHOUT ANY PARTICULAR HEALTH PROBLEMS. THE PATIENT'S CONDITION DETERIORATED ON (B)(6) 2024, WHICH LED TO A PUNCTURE ON (B)(6) 2024 WHICH WAS NOT SUFFICIENT. FOLLOWING THE DETERIORATION OF THE PATIENT'S HEALTH, CATHETER REPOSITIONING HAS BEEN PERFORMED BY DR (B)(6) ON (B)(6) 2024 WHICH WAS INCONCLUSIVE. THE PATIENT DIED AS A RESULT OF A DETERIORATION OF HIS GENERAL HEALTH CONDITION ON (B)(6) 2024. ACCORDING TO THE SURGEON, THE VALVE APPEARED TO BE MALFUNCTIONING.

    Description of Event or Problem · 0

    IMPLANTATION OF A POLARIS KIT REF SPV-2010 HAS BEEN PERFORMED BY DR (B)(6) ON (B)(6) 2024. THE PATIENT WAS HOSPITALISED FROM (B)(6) WITHOUT ANY PARTICULAR HEALTH PROBLEMS. THE PATIENT'S CONDITION DETERIORATED ON (B)(6) 2024, WHICH LED TO A PUNCTURE ON (B)(6) 2024 WHICH WAS NOT SUFFICIENT. FOLLOWING THE DETERIORATION OF THE PATIENT'S HEALTH, CATHETER REPOSITIONING HAS BEEN PERFORMED BY DR (B)(6) ON (B)(6) 2024 WHICH WAS INCONCLUSIVE. THE PATIENT DIED AS A RESULT OF A DETERIORATION OF HIS GENERAL HEALTH CONDITION ON (B)(6) 2024. ACCORDING TO THE SURGEON, THE VALVE APPEARED TO BE MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363650 POLARIS® SPV KIT PREATTACHED / BO19-10 SPV-2010 JXG SOPHYSA SPV-2010

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male Death