BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL CATHETER

    MDR report key: 6432322 · Received March 24, 2017

    Report

    Report Number
    1226348-2017-10182
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    May 8, 2016
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE, UDI UNAVAILABLE. IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED. HOWEVER, ONE OF THE AUTHORS OF THE PRESENTATION WAS CONTACTED AND STATED THAT THE INFECTION REPORTED IN THE STUDY WAS DUE TO THE MULTIPLE PROCEDURES THE PATIENTS WERE EXPOSED TO, WHICH, IN ADDITION TO THEIR ORIGINAL HEALTH ISSUES, MADE THEM MORE PRONE TO INFECTION RISK. ACCORDING TO THE SURGEON, THE INFECTION WAS NOT RELATED TO THE CATHETERS. THE SURGEON STATED THAT THE BACTISEAL CATHETER REDUCED INFECTION RISK SIGNIFICANTLY COMPARED TO OUTCOMES WITHOUT THE BACTISEAL CATHETER. UPON FURTHER DISCUSSION WITH THE AUTHOR, IT DOES NOT APPEAR THAT A DEVICE FAILURE OCCURRED. HOWEVER, WITHOUT ADDITIONAL INFORMATION, A CONCLUSIVE DETERMINATION CAN NOT BE MADE. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    IN THE FLASH PRESENTATION FP094 AT ¿25TH CONGRESS OF THE EUROPEAN SOCIETY FOR PEDIATRIC NEUROSURGERY (ESPN) PARIS-FRANCE, 8-11 MAY 2016¿ TITLED ¿VENTRICULO-SUBGALEAL SHUNT USING AN ANTIBIOTIC IMPREGNATED. CATHETER: A RETROSPECTIVE ANALYSIS OF OUR INSTITUTIONAL EXPERIENCE", PUBLISHED CHILDS NERV SYST (2016) 32:905¿1012 DOI 10.1007/S00381-016-3044-Z, IT WAS REPORTED THAT 2 UNKNOWN PATIENTS DEVELOPED INFECTIONS POST IMPLANTATION OF UNKNOWN BACTISEAL CATHETERS FOR CSF SHUNTING PURPOSES. PER THE ARTICLE: ¿INTRODUCTION: VENTRICULO-SUBGALEAL SHUNT (VSS) IS A TEMPORARY MEASURE TO MANAGE HYDROCEPHALUS, EVENTUALLY OVERCOMING THE RISKS OF EXTERNAL VENTRICULAR DRAINAGE AND SUBCUTANEOUS RESERVOIR. METHODS: WE PERFORMED A RETROSPECTIVE ANALYSIS OF VSS PERFORMED AT OUR INSTITUTION IN THE PERIOD 2013-2015. ANTIBIOTIC IMPREGNATED CATHETER (BACTISEAL®, CODMAN) ALONG WITH A RIGHT ANGLE CONNECTOR WERE USED TO BUILD A PATIENT-TAILORED SHUNT. IN CASE OF COLLAPSED OR TENSE SUBGALEAL POUCH WITH SIGNS OF ELEVATED INTRACRANIAL PRESSURE, REVISION OF THE VSS WAS PERFORMED WHILE TAPPING OF THE POUCH WAS ALWAYS AVOIDED TO REDUCE THE RISK OF INFECTION. PATIENTS WERE MONITORED WITH SERIAL ULTRASOUNDS. RESULTS: WE COLLECTED 36 PATIENTS RECEIVING VSS. MAIN INDICATION WAS POST-HEMORRHAGIC HYDROCEPHALUS IN 32 PRETERM BABIES, FOLLOWED BY POST-INFECTIOUS IN 3 AND SYSTEMIC CONDITIONS CONTRAINDICATING THE IMPLANT OF PERMANENT SHUNT IN A SINGLE CASE. ONE PATIENT ALSO RECEIVED SUBDUROSUBGALEAL SHUNT AND ANOTHER PATIENT RECEIVED AN IV VENTRICLE-SUBGALEAL SHUNT. VSS CONTROLLED HYDROCEPHALUS IN ALL PATIENTS FOR A PERIOD RANGING FROM 15 DAYS TO 9 MONTHS (MEDIAN 32 DAYS). REVISION WAS REQUIRED IN A HALF OF THE CASE. COMPLICATIONS WERE: ONE CASE OF HEMORRHAGE SECONDARY TO ABRUPT VENTRICULAR DRAINAGE, THAT DID NOT REQUIRE ADDITIONAL SURGERY, AND TWO CASES OF INFECTION IN PATIENTS WHO UNDERWENT MULTIPLE SURGICAL PROCEDURES (INCLUDING ENDOSCOPY FOR MULTILOCULATED HYDROCEPHALUS). ALL PATIENTS WERE CONVERTED TO A PERMANENT SHUNT EXCEPT FOR 2 PATIENTS WHO DIED BECAUSE OF COMPLICATIONS OF PREMATURITY AND ONE PATIENT WHO WAS MADE SHUNT-FREE WITH ENDOSCOPIC THIRD-VENTRICULOSTOMY. CONCLUSIONS: VSS IS A SAFE AND EFFECTIVE METHOD TO CONTROL HYDROCEPHALUS IN CRITICAL BABIES. OUR POLICY, BASED ON THE USE OF ANTIBIOTIC-IMPREGNATED CATHETER AND AVOIDANCE OF TAPPING THE SUBGALEAL POUCH, CONTAINED THE RATE OF INFECTION TO ABOUT 5% IN THIS PARTICULAR SUBSET OF PATIENTS. MANAGEMENT OF PATIENTS HARBORING VSS RESULTED EASIER THAN OTHER OPTIONS, SUCH AS EXTERNAL VENTRICULAR DRAINAGE, TO NURSES AND INTENSIVE CARE PHYSICIANS.¿ THE EVENT OF HEMORRHAGE WAS RELATED TO THE SHUNT RATHER THAN THE BACTISEAL CATHETER AND WILL NOT BE CAPTURED AS A COMPLAINT AT THIS TIME. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Description of Event or Problem · 1

    ONE OF THE AUTHORS OF THE PRESENTATION WAS CONTACTED AND STATED THAT THE INFECTION REPORTED IN THE STUDY WAS DUE TO THE MULTIPLE PROCEDURES THE PATIENTS WERE EXPOSED TO, WHICH, IN ADDITION TO THEIR ORIGINAL HEALTH ISSUES, MADE THEM MORE PRONE TO INFECTION RISK. ACCORDING TO THE SURGEON, THE INFECTION WAS NOT RELATED TO THE CATHETERS. THE SURGEON STATED THAT THE BACTISEAL CATHETER REDUCED INFECTION RISK SIGNIFICANTLY COMPARED TO OUTCOMES WITHOUT THE BACTISEAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213197 UNK BACTISEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention