BEUDAMED
    FDA Adverse Event Death Summary report: N

    TISSOMAT AND SPRAY SET

    MDR report key: 2635099 · Received June 29, 2012

    Report

    Report Number
    2954761-2012-00025
    Event Type
    Death
    Date Received
    June 29, 2012
    Date of Event
    June 1, 1990
    Report Date
    June 14, 2012
    Manufacturer
    BAXTER HEALTHCARE - VIENNA
    Product Code
    FMF
    PMA / PMN Number
    K981089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: A FOUR LUMEN SPRAY CATHETER WAS CONNECTED TO THE TISSOMAT REGULATOR TO DELIVER TISSEEL FIBRIN SEALANT. WITHIN SECONDS OF INITIATING THE SPRAY TO DELIVER FIBRIN SEALANT, THE PATIENT LOST CONSCIOUSNESS AND HAD A CARDIAC ARREST. RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL. AUTOPSY REVEALED AIR IN THE RIGHT VENTRICLE. GIVEN THE TEMPORAL RELATIONSHIP OF THE INITIATION OF GAS DELIVERY THROUGH THE FOUR LUMEN CATHETER AND THE ONSET OF SYMPTOMS, THE SPRAY CATHETER USED TO DELIVER BOTH THE FIBRIN SEALANT AND THE COMPRESSED GAS CAUSED THE AIR EMBOLISM. THE TISSOMAT GAS REGULATORY CONTRIBUTED BY PROVIDING THE GAS, HOWEVER WITHOUT THE SPRAY CATHETER, THE GAS WOULD NOT HAVE BEEN ABLE TO BE DELIVERED THROUGH THIS NARROW OPENING. THE USE OF THE TISSOMAT WITH THE CURRENTLY APPROVED SPRAY SET DOES NOT CARRY THIS RISK. THE SPRAY SET INSTRUCTIONS FOR USE CLEARLY STATE TO KEEP BETWEEN THE SPRAY HEAD TIP 10 - 20CM AWAY FROM THE TISSUE AND THE LENGTH OF THE SPRAY HEAD DOES NOT ALLOW FOR INSERTION THROUGH A NARROW CHANNEL OR CAVITY. ADDITIONALLY, THE CURRENTLY MARKETED TISSOMAT HAS UNDERGONE SEVERAL IMPROVEMENTS SINCE 1990 INCLUDING THE ADDITION OF A DOWN REGULATOR AND WARNING STATEMENTS REGARDING THE USE OF COMPRESSED GAS. AS IT WAS THE SPRAY CATHETER WHICH ALLOWED APPLICATION INTO A VERY NARROW ORIFICE THAT CAUSED THIS FATAL EVENT AND NOT THE TISSOMAT GAS REGULATOR, NO FURTHER ACTION IS REQUIRED. THE FOUR LUMEN SPRAY APPLICATION CATHETER WAS SUBSEQUENTLY REMOVED FROM THE GLOBAL MARKET IN 1990.

    Description of Event or Problem · 1

    FROM LITERATURE: V. LANGE, G. MEYER, H. WENK, AND F.W. SCHILDBERG. FISTULOSCOPY - AN ADJUVANT TECHNIQUE FOR SEALING GASTROINTESTINAL FISTULAE (1990). SURGICAL ENDOSCOPY. 1990; 4: 212-216. ONE PATIENT DIED; HE HAD A GASTRECTOMY COMPLICATED BY A SUTURE-LINE RUPTURE WITH A HORSESHOE FISTULA WITH TWO OPENINGS TO THE SKIN. TWO SESSIONS OF CONVENTIONAL GASTROSCOPIC SEALING HAD ALREADY CLOSED ONE ARM OF THE FISTULA. FINAL OCCLUSION OF THE MARKEDLY DIMINISHED SECOND FISTULA ARM SEEMED EASIER TO ACHIEVE BY FISTULOSCOPY THAN BY DIRECT INJECTION OF SEALANT INTO THE ANASTOMOSIS. THE PROCEDURE WAS PERFORMED UNDER DIAZEPAM SEDATION. SOME SECONDS AFTER STATING THE FIBRIN SPRAY GAS FLOW; THE PATIENT LOST CONSCIOUSNESS AND HAD A CARDIAC ARREST. RESUSCITATION WAS UNSUCCESSFUL. AUTOPSY SHOWED THE RIGHT VENTRICLE WAS FILLED WITH AIR, AND DEATH WAS ASSUMED TO BE DUE TO AN AIR EMBOLISM. EXACT DATE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE ON THE CASE AND DUE TO THE AGE OF THE PUBLICATION NO FOLLOW-UP WILL BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSOMAT AND SPRAY SET SYRINGE, PISTON FMF BAXTER HEALTHCARE - VIENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death