BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMMINGBIRD SYNERGYDUO VENTRICULAR

    MDR report key: 4196373 · Received October 10, 2014

    Report

    Report Number
    2084683-2014-00001
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    October 9, 2014
    Manufacturer
    INNERSPACE NEURO SOLUTIONS, INC.
    Product Code
    GWM
    PMA / PMN Number
    K083378
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE(B)(6): THE TIP AND CATHETER BODY WERE DECONTAMINATED AND EXAMINED PER INVESTIGATIONAL PROTOCOL. MICROSCOPIC EXAMINATION OF THE TWO CATHETER SECTIONS DID NOT REVEAL ANYTHING UNUSUAL. THE BOND JOINTS APPEARED NORMAL WITH EVIDENCE OF RESIDUAL ADHESIVE CONSISTENT WITH A SATISFACTORY, IN SPECIFICATION BONDING. IT WAS ALSO NOTED DURING THE EXAMINATION THAT A TAB ON THE INSERT WAS BROKEN OFF, HOWEVER, THE INSERTION ELEMENT COMPRESSION FITTING (CAP, COUPLER AND GASKET) WERE CLEAR, UNOBSTRUCTED AND FUNCTIONED PROPERLY WHEN TIGHTENED OR LOOSENED. IT IS UNCLEAR HOW THIS BREAK OCCURRED. TWO CATHETERS FROM THE SAME LOT WERE SUBJECTED TO A DESTRUCTIVE TENSILE TESTS AND WERE FOUND TO BE IN SPECIFICATION, I.E., GREATER THAN 10 LBS. TO FAILURE. TWO OTHER CATHETERS FROM THE SAME LOT WERE SUBJECTED TO SIMULATED INSERTION TESTS. A PORK STOMACH WAS EMPLOYED TO SIMULATE TRANSITION THROUGH DURA. THE TISSUE SAMPLE WAS PREPARED WITH AN 18 GA X 3.5 INCH NEEDLE. BOTH CATHETERS WERE INSERTED WITH FORCE (THE CATHETER/STYLET "BOWED" UPON INSERTION) AND FINALLY PROPAGATED A TEAR AND TRANSITIONED THROUGH THE MODEL. AUDIBLE "POPS" WERE HEARD IN BOTH CASES. CONCLUSION: THE CAUSE OF THE SEPARATION OF THE TIP FROM THE CATHETER BODY CANNOT BE DETERMINED, BUT IT IS SUSPECTED THAT THE DIFFICULTY EXPERIENCED DURING THE INSERTION PROCEDURE PLAYED A ROLE. NO ADDITIONAL ACTION IS REQUIRED. FIELD EXPERIENCE WILL BE MONITORED FOR SIMILAR OCCURRENCE.

    Description of Event or Problem · 1

    THIS INCIDENT IS CONSIDERED AN ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. AN H600 VENTRICULAR DRAINAGE CATHETER WAS PLACED BY A RESIDENT PHYSICIAN (B)(6) 2014. A PROBLEM WAS ENCOUNTERED AND INNERSPACE WAS CONTACTED (B)(4). A SENIOR ENGINEER WAS ON SITE THE NEXT DAY TO INVESTIGATE. THE FOLLOWING ACCOUNT IS BASED ON CONVERSATIONS WITH THE RESIDENT WHO PLACED THE CATHETER, THE SENIOR RESIDENT AND ATTENDING NEUROSURGEON. DETAILS OF CATHETER PLACEMENT BY THE RESIDENT: AN ACCESS HOLE WAS DRILLED, THE BOLT WAS SECURED AND THE INSERT WAS ENGAGED WITHOUT INCIDENT. THE EXPECTED "DOUBLE CLICK" WAS HEARD AS THE INSERT WAS POSITIONED. THE RESIDENT POSITIONED THE STYLET IN THE CATHETER BODY AND ATTEMPTED TO ACCESS THE VENTRICLE. HE ENCOUNTERED RESISTANCE IMMEDIATELY AND JUDGING FROM THE DEPTH MARKER ON THE CATHETER, THE TIP WAS IN THE VICINITY OF THE DURA. ADDITIONAL PRESSURE WAS APPLIED, THEN THERE WAS A "POP" SOUND AND THE CATHETER ADVANCED. THE CATHETER WAS ADVANCED TO ACCESS THE VENTRICLE. AT DEPTH MARKER 6 THE CATHETER HAD ENTERED THE VENTRICLE AND CFS WAS OBSERVED DRAINING FROM THE CATHETER. FOR SOME REASON OR OTHER THE RESIDENT FELT "SOMETHING WAS WRONG," AND REMOVED THE CATHETER. BOTH THE INSERT AND THE CATHETER WERE REPLACED WITHOUT INCIDENT. THE SECOND CATHETER WAS PLACED UNEVENTFULLY. DETAILS OF FOLLOW UP POST CATHETER REMOVAL: CATHETER EXAMINATION SUBSEQUENT TO REMOVAL REVEALED THE TIP OF THE CATHETER WAS MISSING. THE CATHETER WAS PROVIDED TO THE INNERSPACE REPRESENTATIVE FOR FURTHER EVALUATION. A CT SCAN WAS PERFORMED AND CONFIRMED THE TIP WAS DETACHED AND LEFT BEHIND. IT IS CURRENTLY NOT CLEAR HOW AND WHY THE CATHETER TIP BECAME DISLODGED. THE TIP OF THE CATHETER WAS IMAGED AND FOUND TO BE SHALLOW IN THE VENTRICLE. IT WAS SUBSEQUENTLY RETRIEVED WITHOUT INCIDENT. THE TIP AND CATHETER BODY WERE SENT TO INNERSPACE FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643182 HUMMINGBIRD SYNERGYDUO VENTRICULAR ICP MONITORING DEVICE GWM INNERSPACE NEURO SOLUTIONS, INC. H600 131202-06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention