BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS SPVA KIT PREATTACHED/BO19-10

    MDR report key: 2240668 · Received December 17, 2007

    Report

    Report Number
    3001587388-2007-00379
    Event Type
    Other
    Date Received
    December 17, 2007
    Date of Event
    October 16, 2007
    Report Date
    December 11, 2007
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED FAILURE CAN BE CONFIRMED. THE DISTAL CATHETER APPEARS TO HAVE BURST FOLLOWING A STRONG INTERNAL SHUNT OVER-PRESSURIZATION. THE RESERVOIR ALSO SHOWS SIGNS OF INJECTION. THE DEVICE HISTORY FILE DEMONSTRATES BOTH THE CATHETER AND THE RESERVOIR CONFORMING TO MANUFACTURING SPECIFICATIONS. ONE HYPOTHESIS CAN BE ADVANCED TO EXPLAIN THIS ISOLATED EVENT: THE NEUROSURGEON MAY HAVE DETERMINED THAT THE SHUNT WAS OCCLUDED, AND THAT NORMAL CSF DRAINAGE HAD CEASED. IN ORDER TO TEST THE SHUNT'S PATENCY, THE IMPLANTED CATHETER WAS PROBABLY EXPOSED TO A PRESSURE IN EXCESS OF ITS BURSTING RESISTANCE BY AN UNUSUALLY HIGH INJECTION PRESSURE, WITH A SYRINGE SMALLER THAN 10 ML, INSIDE THE RESERVOIR, AFTER CLAMPING THE VENTRICULAR CATHETER. NO CORRECTIVE ACTION WAS DECIDED, AS THIS IS THE FIRST CASE OF A BURSTING CATHETER TO HAVE BEEN REPORTED TO SOPHYSA. THE INSTRUCTIONS FOR USE GIVE THOROUGH HANDLING PRECAUTIONS FOR PATENCY TESTING, AS WELL AS RECOMMENDATIONS FOR RESERVOIR INJECTIONS, AND CSF SAMPLING. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSPITAL FOR REMOVAL OF HIS VENTRICULOPERITONEAL (VP) SHUNT SECONDARY TO A GROWING SUBCUTANEOUS FLUID COLLECTION ALONG THE LEFT SIDE OF HIS NECK. A SHUNT SERIES WAS PERFORMED AND SHOWED EVIDENCE OF A SHUNT DISCONNECTION OF THE CERVICAL THORACIC JUNCTION. THE PT'S SHUNT WAS SUSPECTED OF SHUNT DISCONNECTION/FRACTURE. AT THE TIME OF SURGERY, IT WAS DETERMINED THAT THE PERITONEAL CATHETER TUBING WAS SHEARED DISTAL TO THE VALVE ASSEMBLY. THE VP SHUNT VALVE AND PORTION OF THE PROXIMAL PERITONEAL CATHETER WAS REMOVED. THE ABDOMINAL PART OF THE CATHETER WAS NOT RETRIEVED/THE PT AUTHORIZED THE HOSPITAL TO SEND HIS SURGICALLY REMOVED VP SHUNT TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS SPVA KIT PREATTACHED/BO19-10 HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE R0327

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention